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Completed

NCT Number: NCT02565615

Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting

The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。

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Key information

Conditions

Coronary Artery Disease, Hypercholesterolemia, Hypertension Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First People's Hospital of Fuyang City, Fuyang, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged ≥18 years;
  • Cardiology patients who has been prescribed atorvastatin by physician's clinical judgment under normal clinical care. These patients will include those with established coronary heart disease, or having multiple risk factors and at risk for cardiovascular disease, or primary hypercholesterolemia.
  • Baseline laboratory reports prior to starting atorvastatin therapy can be tracked , including lipid measurement, liver function, and Creatine Kinase (CK) value. The date of baseline reports should be within 1 month before taking atorvastatin or within 24h after starting atorvastatin therapy.
  • Evidence of a personally or his/her legally acceptable representative signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study and accept follow-up visit.

Exclusion criteria

  • Patients who have regularly taken atorvastatin therapy more than 4 weeks before enrollment
  • Concomitant any other lipid-lower medication at baseline, or during the study conduction on physician clinical judgement

Treatment and study plan

No intervention

Other

Because this is a non-interventional study, there is no intervention here.

Primary outcomes

  1. Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall

    Time frame: 12 weeks

    Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.

  2. Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level

    Time frame: 12 weeks

    Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Secondary outcomes

  1. Change From Baseline for Lipid Parameters at Week 12 for Overall

    Time frame: Baseline to Week 12

    Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline data was reported.

  2. Percent Change From Baseline for Lipid Parameters at Week 12 for Overall

    Time frame: Baseline to Week 12

    Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.

  3. Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group

    Time frame: Baseline to Week 12

    Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline data was reported.

  4. Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level

    Time frame: Baseline to Week 12

    Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.

  5. Study Drug Exposure for Overall - Total Dose and Week 12 Dose

    Time frame: Day 1 to Week 12

    Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12

  6. Study Drug Exposure for Overall - Daily Dose

    Time frame: Day 1 to Week 12

    Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.

  7. Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose

    Time frame: Day 1 to Week 12

    Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  8. Study Drug Exposure Within Each CVD Risk Group -Daily Dose

    Time frame: Day 1 to Week 12

    Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  9. Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall

    Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )

    All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.

  10. Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level

    Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )

    All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  11. Number of Participants With Adverse Events of Special Interest (AESI) for Overall

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)

    AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death.

  12. Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level

    Time frame: Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  13. Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range.

  14. Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk

    Time frame: Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  15. Change From Baseline for Clinical Laboratory Overall- ALT and AST

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported.

  16. Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported.

  17. Change From Baseline for Clinical Laboratory Overall- Creatine Kinase

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported.

  18. Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)

    The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  19. Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  20. Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase

    Time frame: Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)

    The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5%~10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%~15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

  21. Precentage of Participants With Discontinuation From the Study for Overall

    Time frame: 12 weeks of follow-up

    Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.

  22. Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level

    Time frame: 12 weeks of follow-up

    Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

ATORVASTATIN EFFECTIVENESS AND SAFETY IN CARDIOLOGY PATIENTS IN REAL WORLD SETTING: A REGISTRY STUDY IN CHINA

Acronym: ATTENTION

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2015
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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