Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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-opening of the blocked vessel. The no-reflow were commonly attributed to tiny blockage in coronary micro-vasculature by thrombus and spasm of the micro-vessel during stenting.

An agent with more effective anti-clotting and micro-vessel dilation would be helpful to solve the issue of no-reflow. Ticagrelor was demonstrated to be a potent platelet inhibitor and a potent micro-vessel dilator which can influence metabolism of adenosine, a endogenous potent small vessel dilator.

This study is to test the effectiveness of ticagrelor on improving reperfusion and minimizing the myocardial infarct size after PPCI in patients with AMI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Hospital of China Medical University
• Collaborator: AstraZeneca
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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