Ticagrelor and Intracoronary Morphine in Patients Undergoing Primary Percutaneous Coronary Intervention
Effects of Ticagrelor and Intracoronary Morphine on Myocardial Salvage in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
1 other identifier
interventional
100
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 23, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 6, 2016
October 1, 2014
4.3 years
November 23, 2012
July 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Myocardial infarct size measured by magnetic resonance imaging (MRI) at 3-5 days after the index procedure
Post-PCI 3-5 days
Secondary Outcomes (7)
Rate of complete ST-segment resolution on ECG obtained 30 minutes after the procedure
30 min after completion of PCI
Enzymatic Infarct size by creatine kinase-MB (area under curve)
1 month later
Myocardial salvage index measured by MRI
Post-PCI 3-5 days
Major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis)
1Month later
The extent of microvascular obstruction measured by MRI
post-PCI 3-5days
- +2 more secondary outcomes
Study Arms (4)
Ticagrelor + Intracoronary Morphine
EXPERIMENTAL180 mg loading pre-PCI followed by 90 mg bid for 5 days. Intracoronary Morphine Sulfate 3 mg + Saline 3 ml mix.
Ticagrelor + Intracoronary Saline
EXPERIMENTAL180 mg loading pre-PCI followed by 90 mg bid for 5 days. Saline 3 ml intracoronary injection.
Clopidogrel + Intracoronary Morphine
EXPERIMENTAL600 mg loading pre-PCI followed by 75 mg qd for 5 days. Morphine Sulfate 3 mg + Saline 3 ml mix intracoronary injection.
Clopidogrel + Intracoronary Saline
ACTIVE COMPARATOR600 mg loading pre-PCI followed by 75 mg qd for 5 days. Saline 3 ml intracoronary injection.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- TIMI flow grade 0 or 1 of infarct related arteries
You may not qualify if:
- 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).
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hyeon-Cheol Gwonlead
Study Sites (1)
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, 135-710, South Korea
Related Publications (2)
Kim EK, Park TK, Yang JH, Song YB, Choi JH, Choi SH, Chun WJ, Choe YH, Gwon HC, Hahn JY. Ticagrelor Versus Clopidogrel on Myocardial Infarct Size in Patients Undergoing Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Apr 25;69(16):2098-2099. doi: 10.1016/j.jacc.2017.02.034. No abstract available.
PMID: 28427585DERIVEDGwag HB, Kim EK, Park TK, Lee JM, Yang JH, Song YB, Choi JH, Choi SH, Lee SH, Chang SA, Park SJ, Lee SC, Park SW, Jang WJ, Lee M, Chun WJ, Oh JH, Park YH, Choe YH, Gwon HC, Hahn JY. Cardioprotective Effects of Intracoronary Morphine in ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Prospective, Randomized Trial. J Am Heart Assoc. 2017 Apr 3;6(4):e005426. doi: 10.1161/JAHA.116.005426.
PMID: 28373244DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyeon-Cheol Gwon, MD/PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 23, 2012
First Posted
November 30, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 6, 2016
Record last verified: 2014-10