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Comparison Of Efficacy and Safety Between Ticagrelor and Clopidogrel In Chinese (COSTIC)

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ClinicalTrials.gov Identifier: NCT03239067
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dao Wen Wang, Tongji Hospital

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.

Condition or disease
Acute Coronary Syndrome

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Study Type : Observational
Estimated Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 1, 2014
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
ticagrelor group
patients prescribed with ticagrelor
clopidogrel group
patients prescribed with clopidogrel



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Composite incidence of all-cause death, myocardial infarction and stroke [ Time Frame: 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.

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


Other Outcome Measures:
  1. Incidence of safety endpoints [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese patients with acute coronary syndrome undergoing percutaneous coronary syndrome
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239067


Contacts
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Contact: Yang Sun, MD candidate 86-27-83663280 d201578301@hust.edu.cn

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Yang Sun, MD candidate    86-27-83663280    d201578301@hust.edu.cn   
Sponsors and Collaborators
Tongji Hospital
Investigators
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Study Chair: Dao Wen Wang, Doctor Tongji Hospital,Wuhan, Hubei, China, 430030

Publications:
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Responsible Party: Dao Wen Wang, Prof., Tongji Hospital
ClinicalTrials.gov Identifier: NCT03239067     History of Changes
Other Study ID Numbers: TJH-COSTIC
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

Keywords provided by Dao Wen Wang, Tongji Hospital:
Ticagrelor
Clopidogrel
Acute Coronary Syndrome
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
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Myocardial Ischemia
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs