Acute Coronary Syndrome
Conditions
Keywords
Ticagrelor, Clopidogrel, Acute Coronary Syndrome, Percutaneous Coronary Intervention
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.
Interventions
None listed
Sponsors
Tongji Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of safety endpoints | 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. |
Countries
China
Outcome results
None listed