Clinical trial NCT03239067: Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Ticagrelor
Clopidogrel
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 9040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients with acute coronary syndrome undergoing percutaneous coronary syndrome

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite incidence of vascular death, myocardial infarction and stroke
timeFrame: up to 12 months
Secondary outcomes:
measure: Composite incidence of all-cause death, myocardial infarction and stroke
timeFrame: up to 12 months
measure: Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events
timeFrame: up to 12 months
Other outcomes:
measure: Incidence of safety endpoints
timeFrame: up to 12 months
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital,Wuhan, Hubei, China, 430030
name: Dao Wen Wang, Doctor
role: STUDY_CHAIR
References:
citation: Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.
citation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
citation: Sun Y, Li C, Zhang L, Yu T, Ye H, Yu B, Tao M, Jiang J, Yan J, Wang Y, Zeng H, Shen X, Wang DW. Clinical outcomes after ticagrelor and clopidogrel in Chinese post-stented patients. Atherosclerosis. 2019 Nov;290:52-58. doi: 10.1016/j.atherosclerosis.2019.09.011. Epub 2019 Sep 21.