Status:
UNKNOWN
Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI
Lead Sponsor:
First Hospital of China Medical University
Collaborating Sponsors:
AstraZeneca
Conditions:
Myocardial Infarction
No-Reflow Phenomenon
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The patients with acute myocardial infarction (AMI) present high mortality and morbidity rate,even treated with stenting in the blocked heart vessels. The appearance of no-reflow is common after re-o...
Detailed Description
The patients with acute myocardial infarction (AMI) present high mortality and morbidity rate, and also have malignant prognosis even if they could survive. The mortality and prognosis has been improv...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Patients with acute ST-segment elevation myocardial infarction, an onset of symptoms presented within 12 hours. Two criteria have to be met: persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block, and the intention to perform primary PCI
- Patients must agree to undergo all protocol-required follow-up examinations and not to participate any other clinical trials within the duration of this study
Exclusion
- Any contraindication against the use of clopidogrel or ticagrelor
- Fibrinolytic therapy within 24 hours before randomization
- Stroke within the previous 6 months or intracranial hemorrhage at any time before randomization
- Any other concomitant severe organic or systemic disorder, such as severe liver (ALT\>3×ULN )or renal disease(creatinin\>5.0mg/dl or 442μmol/L), etc.
- A need for oral anticoagulation therapy
- An increased risk of bradycardia or atrial-ventricle block
- Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
- Pregnant women or breast-feeding, or planning to become pregnant while enrolled in this study
- Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT02233790
Start Date
December 1 2014
End Date
December 1 2016
Last Update
September 8 2014
Active Locations (1)
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1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001