Acute Coronary SyndromeCOSTICNCT03239067
Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese
An observational study of Acute Coronary Syndrome, run by Tongji Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 9,040 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2014to 24 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patients with acute coronary syndrome undergoing percutaneous coronary syndrome
Who may be able to join
- 18 years of age or older;
- diagnosed as acute coronary syndrome;
- underwent successful percutaneous coronary intervention.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ticagrelor group | patients prescribed with ticagrelor | |
| clopidogrel group | patients prescribed with clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (2)
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.
Measured: up to 12 months
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Aug 2014
- Primary completion24 Oct 2021
- Study completion24 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
- Investigators
- Dao Wen Wang, Doctor, Study chair, Tongji Hospital,Wuhan, Hubei, China, 430030
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239067
- Sponsor's protocol ID
- TJH-COSTIC
- Acronym
- COSTIC
- Status last verified
- Nov 2021
- First submitted
- 27 Jul 2017
- Last updated
- 29 Nov 2021
- Results posted
- No
Publications
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.
PubMed 22923432Mehran 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.
PubMed 21670242Hu 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.
PubMed 41034995Sun 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.
PubMed 31568962
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03239067
- Acronym / sponsor ID
- COSTIC / TJH-COSTIC
- Conditions
- Acute Coronary Syndrome
- Keywords
- Ticagrelor, Clopidogrel, Acute Coronary Syndrome, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,040 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 24 Oct 2021 (actual)
- Study completion
- 24 Oct 2021 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ticagrelor group | – | –patients prescribed with ticagrelor |
| clopidogrel group | – | –patients prescribed with clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with acute coronary syndrome undergoing percutaneous coronary syndrome
Key inclusion criteria (3 listed)
- 18 years of age or older;
- diagnosed as acute coronary syndrome;
- underwent successful percutaneous coronary intervention.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite incidence of vascular death, myocardial infarction and stroke
Time frame: 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.
2 secondary outcomes
Composite incidence of all-cause death, myocardial infarction and stroke
Time frame: up to 12 months
Composite incidence of vascular death, myocardial infarction, stroke, recurrent ischemia, transient ischemic attack, or other arterial thrombotic events
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Background: PubMed 22923432Thygesen 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.
- Background: PubMed 21670242Mehran 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.
- Derived from this study: PubMed 41034995Hu 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.
- Derived from this study: PubMed 31568962Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dao Wen Wang, Doctor study chair
Tongji Hospital,Wuhan, Hubei, China, 430030
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of vascular death, myocardial infarction and stroke (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03239067, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.