Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ticagrelor group<br>patients prescribed with ticagrelor | |
| clopidogrel group<br>patients prescribed with clopidogrel | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite incidence of vascular death, myocardial infarction and stroke | 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. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite incidence of all-cause death, myocardial infarction and stroke | 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. | up to 12 months | 
| Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events | 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. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Clopidogrel, Acute Coronary Syndrome, Percutaneous Coronary Intervention