Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT03239067
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-01
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-03
• Primary Completion: 2021-10-24
• Study Completion: 2021-10-24
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9040

Inclusion Criteria

1. 18 years of age or older;
2. diagnosed as acute coronary syndrome;
3. underwent successful percutaneous coronary intervention.

Exclusion Criteria

1. participate in any drug clinical trials within 3 months;
2. patients with life-threatening complications, or the researchers determined that the survival time of patients with no more than 1 years;
3. serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
4. 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);
5. patients refused to comply with the requirements of this study to complete the research work.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite incidence of vascular death, myocardial infarction and stroke	up to 12 months	1. Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.; 2. The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).; 3. 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 Outcome Measures

Name	Time	Method
Composite incidence of all-cause death, myocardial infarction and stroke	up to 12 months	1. All-cause death was defined as any death at hospital or after discharge.; 2. The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction.; 3. 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.
Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events	up to 12 months	1. Vascular death was defined as death from cardiovascular causes or cerebrovascular causes and any unknown death unless there was another certain cause.; 2. The definition of myocardial infarction was consistent with the Third Universal Definition of Myocardial Infarction (1).; 3. 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.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China