Ticagrelor and Intracoronary Morphine in Patients Undergoing Primary Percutaneous Coronary Intervention

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

Summary

A 2 by 2 factorial, multicenter, prospective, randomized, open-label, blinded endpoint trial. Patients undergoing primary PCI for STEMI will be eligible. Enrolled patients will be randomly assigned to the ticagrelor group or the clopidogrel group in a 1:1 ratio. After emergent coronary angiography, patients who have thrombolysis in myocardial infarction (TIMI) flow grade <2 in coronary angiogram will be randomized again, to either bolus intracoronary injection of morphine sulfate or saline in a 1:1 ratio. Randomization will be stratified by infarct location (anterior vs. non-anterior), and morphine use for pain control before study enroll (for only intracoronary morphine).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hyeon-Cheol Gwon
• Treatments: Clopidogrel; Morphine; Ticagrelor; Ticlopidine

Criteria

1. Inclusion criteria

• Subject must be at least 20 years of age.

• Patients undergoing primary PCI for STEMI

• Diagnosis of STEMI: ST-segment elevation >0.1 millivolt in ≥2 contiguous leads or (presumably) new left bundle branch block

• Presence of symptoms less than 12 hours

• Additional inclusion criteria for intracoronary morphine

• TIMI flow grade 0 or 1 of infarct related arteries

2. Exclusion Criteria:

• Known hypersensitivity or contraindication to study medications or contrast

• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.

• Rescue PCI after thrombolysis or facilitated PCI

• Cardiogenic shock or cardiopulmonary resuscitation before randomization

• Known chronic hepatic disease

• Known renal dysfunction (creatinine level 3.0mg/dL or dependence on dialysis).

• Decompensated chronic obstructive pulmonary disease or active asthma at inclusion

• Mechanical ventilation at inclusion

• Brain injury or intracranial hypertension

• Acute alcohol intoxication

• Known ulcerative colitis

• Active epilepsy

• Contraindications to undergo MRI imaging include any of the following

• A cardiac pacemaker or implantable defibrillator; any implanted or magnetically activated device; or any history indicating contraindication to MRI including claustrophobia or allergy to gadolinium

• Current use of oral anticoagulant

• An increased risk of bradycardia

• Sinus node dysfunction, atrioventricular dysfunction, or heart rate <40/min

• Patients receiving clopidogrel 300 mg or more before randomization

• One of followings

• history of intracranial bleeding

• intracranial tumor, arteriovenous malformation or aneurysm

• stroke within past 3 months

• Active bleeding of internal organ or bleeding diathesis

• Acute aortic dissection