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Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI (COMPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435133
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pedro L Sanchez, AORTICA Group

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

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: Prasugrel Drug: Ticagrelor Not Applicable

Detailed Description:

Dual antiplatelet therapy consisting of aspirin and one of the P2Y12 receptor inhibitors is the mainstay of treatment for patients with ST elevation acute myocardial infarction undergoing primary percutaneous coronary intervention. Prasugrel or ticagrelor have actually shown to be superior to clopidogrel improving the prognosis of these patients. However, the industrial interest has avoided any direct comparison between these two antiplatelets. Comparison is of great interest considering that only ticagrelor has shown to significantly reduce mortality. As ticagrelor may exert off-target effects through adenosine-related mechanisms, the investigators aimed to investigate whether ticagrelor reduces myocardial injury to a greater extent than prasugrel in patients with revascularized STEMI.

Patients with acute STEMI undergoing primary percutaneous coronary revascularization within 6 hours of chest pain, will be randomized to (1) prasugrel (a 60 mg oral loading and a 10-mg dailiy maintenance dose) or to (2) ticagrelor (a 180 mg loading dose and a 90 mg twice daily maintenance dose). The predefined primary end point is infarct sieze on magnetic resonance imaging at the end of the study (6 months). Magnetic resonance will be performed at day 1, day 7 and moth 6. Platelet reactivity, biomarkers and clinical outcomes will also be assesed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients
Actual Study Start Date : November 23, 2015
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Prasugrel Drug: Prasugrel
60 mg oral bolus plus oral 10 mg once daily

Active Comparator: Ticagrelor Drug: Ticagrelor
180 mg oral bolus plus oral 90 mg every 12 hours daily




Primary Outcome Measures :
  1. Infarct size [ Time Frame: 6 months ]
    Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)


Secondary Outcome Measures :
  1. Infarct size [ Time Frame: up to two weeks ]
    Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)

  2. Myocardial salvage index [ Time Frame: up to two weeks ]
    Cardiac magnetic resonance imaging-assessed myocardial salvage index

  3. Microvascular obstruction [ Time Frame: up to two weeks ]
    Cardiac magnetic resonance imaging-assessed microvascular obstruction

  4. MACE [ Time Frame: 6 months ]
    The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435133


Locations
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Spain
Pedro Dorado
Salamanca, Spain, 37007
Sponsors and Collaborators
AORTICA Group
Investigators
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Principal Investigator: Pedro L Sanchez, MD, PhD Hospital Universitario Salamanca
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Responsible Party: Pedro L Sanchez, Head of Cardiology, PhD, MD, AORTICA Group
ClinicalTrials.gov Identifier: NCT03435133    
Other Study ID Numbers: CARDIO2015.1
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pedro L Sanchez, AORTICA Group:
Primary angioplasty
Prasugrel
Ticagrelor
STEMI
cardiac magnetic resonance
infarct size
infarct injury
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs