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Completed

NCT Number: NCT03239067

Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese

This is a prospective, single-center study to assess the long- and short-term outcomes of ticagrelor vs clopidogrel in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention. Patients will undergo face-to-face interviews, phone calls, or/and chart reviews at 7 days, 1 month, 6 months and 12 months. When 4500 patients have completed the follow-up, an interim analysis will be performed.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older;
  • diagnosed as acute coronary syndrome;
  • underwent successful percutaneous coronary intervention.

Exclusion criteria

  • participate in any drug clinical trials within 3 months;
  • patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
  • serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
  • previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
  • patients refused to comply with the requirements of this study to complete the research work.

Treatment and study plan

Primary outcomes

  1. Composite incidence of vascular death, myocardial infarction and stroke

    Time frame: up to 12 months

    • Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.
    • The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).
    • Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.

Secondary outcomes

  1. Composite incidence of all-cause death, myocardial infarction and stroke

    Time frame: up to 12 months

    • All-cause death was defined as any death at hospital or after discharge.
    • The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.
    • Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.

  2. Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events

    Time frame: up to 12 months

    • Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.
    • The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).
    • Stroke was defined as a rapid onset of a new focal loss of neurologic function caused by an ischemic central nervous system event with residual symptoms lasting at least 24 hours from their onset or leading to death.

Other outcomes

  1. Incidence of safety endpoints

    Time frame: up to 12 months

    Safety endpoints were defined according to the TIMI bleeding criteria.(2) Major bleeding (not related to heart surgery) was defined as fatal-, or intracranial bleeding including any clinically overt signs of hemorrhage associated with a decreased hemoglobin levels (≥5g/dl). Minor bleeding was defined as any clinically overt bleeding leading to decrease in hemoglobin levels of 3 to 5 g/dL or any bleeding requiring medical intervention. Minimal bleeding was defined as any overt bleeding event that did not meet the above criteria. An independent blinded central committee adjudicated all suspected endpoint event.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Comparison of Short- and Long-term Efficacy and Safety Between Ticagrelor and Clopidogrel in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Acronym: COSTIC

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2017
Registry last updated
Nov 29, 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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