Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese

NCT03239067 | Completed

• 1 other identifier: TJH-COSTIC
• Study Type: observational
• Target: 9,040
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Ticagrelor; Clopidogrel; Acute Coronary Syndrome; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Composite incidence of vascular death, myocardial infarction and stroke

  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.

  up to 12 months

Secondary Outcomes (2)

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

  up to 12 months

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

  up to 12 months

Other Outcomes (1)

• Incidence of safety endpoints

  up to 12 months

Study Arms (2)

ticagrelor group

patients prescribed with ticagrelor

clopidogrel group

patients prescribed with clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with acute coronary syndrome undergoing percutaneous coronary syndrome

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (4)

• 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.

  PMID: 22923432 BACKGROUND

• 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.

  PMID: 21670242 BACKGROUND

• Hu S, Yan H, Sun Y, Wang D, Zeng H, Cui G. Triglyceride glucose index in patients with acute coronary syndrome undergoing percutaneous coronary intervention predicts cardiovascular events: a cohort study. Cardiovasc Diabetol. 2025 Oct 1;24(1):380. doi: 10.1186/s12933-025-02937-9.

  PMID: 41034995 DERIVED

• 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.

  PMID: 31568962 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Dao Wen Wang, Doctor

  Tongji Hospital,Wuhan, Hubei, China, 430030

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 3, 2017
• Study Start: August 1, 2014
• Primary Completion: October 24, 2021
• Study Completion: October 24, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

CN (1)