Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI
COMPARE
Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients
1 other identifier
interventional
61
1 country
1
Brief Summary
The investigators propose to perform a randomized clinical trial comparing prasugrel vs. ticagrelor in 60 patients with ST elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The principal objective of the study would be analyzing the difference in myocardial infarction size measured by cardiac magnetic resonance at 6 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2015
CompletedFirst Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJune 10, 2019
June 1, 2019
2.9 years
February 5, 2018
June 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct size
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
6 months
Secondary Outcomes (4)
Infarct size
up to two weeks
Myocardial salvage index
up to two weeks
Microvascular obstruction
up to two weeks
MACE
6 months
Study Arms (2)
Prasugrel
ACTIVE COMPARATORTicagrelor
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age 18 years or older and equal or less than 75 years
- symptom onset within 12 hours before random assignment
- chest pain lasting more than 30 minutes
- ST-segment elevation of at least 0.1 mV in at least 2 limb leads, ST-segment elevation of at least 0.2 mV in 2 or more contiguous precordial leads, or left bundle-branch block or paced rhythm
- time from symptoms onset to randomization less than 6 hours
- no severe heart failure (Killip class \<3)
- informed, written consent
You may not qualify if:
- history of myocardial infarction with Q wave
- history of surgical or percutaneous coronary revascularization
- cardiogenic shock, defined as a systolic blood pressure \<90 mm Hg with no response to fluid administration or \<100 mm Hg in patients with supportive treatment and no bradycardia
- history of stroke
- history of bronchial asthma
- symtomatic sinusal bradicardia or advance AV block
- history of hypersensitivity to aspirin, prasugrel or ticagrelor or contraindication to the doses established in the study
- patients pretreated with 600 mg of clopidogrel or more
- contraindication for the use of gadolinium during the magenitc resonance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AORTICA Grouplead
Study Sites (1)
Pedro Dorado
Salamanca, 37007, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro L Sanchez, MD, PhD
Hospital Universitario Salamanca
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiology, PhD, MD
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 15, 2018
Study Start
November 23, 2015
Primary Completion
October 30, 2018
Study Completion
December 31, 2018
Last Updated
June 10, 2019
Record last verified: 2019-06