Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese

Acute Coronary Syndrome Clinical Trial

— COSTIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239067
• Other study ID #: TJH-COSTIC
• Status: Completed
• Start date: August 1, 2014
• Est. completion date: October 24, 2021

Study information

• Verified date: November 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9040
• Est. completion date: October 24, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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, Menasché 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of safety endpoints	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.	up to 12 months
Primary	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	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
Secondary	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