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Completed

NCT Number: NCT05050773

Registry Study of Medical Therapy in Patients With Angina Pectoris(GREAT)

The study will be a multi-center, prospective, cohort study based on registration of Chinese angina pectoris patients. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 1500 eligible patients will be enrolled. Two natural cohort will be formed according to whether Nicorandil will be prescribed to patients or not. The baseline information of patients will be recorded and patients will be followed up to observe the effectiveness of different anti-angina regimens. Follow-up visits will be conducted at Month 3, 6, 9, 12 after enrollment. The visits at Months 3, 6 and 9 will be conducted in the form of electronic patient reported outcomes (ePRO) + telephone follow-up, and the visit at Month 12 will be conducted on site. Patients are required to fill in the patient diary records (weekly) during the course of the study.

This study is designed to establish a cohort of Chinese angina pectoris patients and compare the effectiveness of different anti-angina regimens in patients with angina pectoris.

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Key information

Conditions

Angina Pectoris Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Real World Study Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

After having signed informed consent (Day 0), the patients will be screened for enrollment. About 1500 eligible patients will be enrolled in this study. The basic information of eligible patients including demographic characteristics, history of present illness, past history, Rose questionnaire, vital sign, medication information, SAQ and other optional examination data will be collected at Day 0. At Day 0, the patients will join the study Wechat Mini Program developed for online follow up and patient education by scan the QR code provided by investigators. After enrollment, the following information will be collected by ePRO with WeChat Mini Program or telephone follow up of month 3, 6 and 9: vital sign, medication information, SAQ, AE. The follow up of month 12 will be conducted on site which will collect SAQ, AE and other optional examination data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-

  • Patients with angina pectoris who have evidence of coronary angiography or coronary computed tomography angiography (CTA) performed within 1 year and meet any of the following requirements:
  • Imaging examination shows ≥ 50% stenosis and with typical or atypical angina symptoms;
  • Imaging examination shows < 50% stenosis; with typical or similar angina symptoms, and the treadmill exercise test or stress echocardiography or radionuclide stress test results are positive;
  • Post-PCI stenosis of left vessels is ≥ 50%; 2. Currently taking or judged by the physicians as suitable to taking at least one oral antianginal drug (e.g., beta-blockers, nitrates, calcium antagonists and potassium channel openers); 3. Have basic reading and writing abilities, and can correctly fill in the Seattle Angina Questionnaire(SAQ) after being trained by the investigator; 4. Able to use smart phones; 5. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

  • Have been diagnosed with malignant tumors that seriously threaten survival and have expected survival time of less than 1 year;
  • Have participated in other clinical studies within the past 1 month;
  • With poor compliance or with other conditions unsuitable for this study as assessed by physicians.

Treatment and study plan

Primary outcomes

  1. SAQ-SS change at Month 12

    Time frame: at Month 12

    Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline

Secondary outcomes

  1. SAQ-SS change at Month 3, 6 and 9

    Time frame: at Month 3, 6 and 9

    Changes in Seattle Angina Questionnaire (SAQ) summary score at Months 3, 6, and 9 from baseline

  2. Vascular stenosis degree change at Month 12

    Time frame: at Month 12

    Changes in retest results of vascular stenosis imaging at Month 12 from baseline

  3. Medication compliance

    Time frame: 12 Month

    Medication compliance evaluated by proportion of days covered (PDC)

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

  • Beijing Life oasis public service center

Registry information

Official study title

A Real-world Study of Clinical Characteristics, Treatment Patterns and Effectiveness in Chinese Patients With Angina Pectoris

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2021
Registry last updated
Aug 1, 2023

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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