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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Prasugrel
Ticagrelor
Sponsored by
AORTICA Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Primary angioplasty, Prasugrel, Ticagrelor, STEMI, cardiac magnetic resonance, infarct size, infarct injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pedro Dorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prasugrel

Ticagrelor

Arm Description

Outcomes

Primary Outcome Measures

Infarct size
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)

Secondary Outcome Measures

Infarct size
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Myocardial salvage index
Cardiac magnetic resonance imaging-assessed myocardial salvage index
Microvascular obstruction
Cardiac magnetic resonance imaging-assessed microvascular obstruction
MACE
The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization

Full Information

First Posted
February 5, 2018
Last Updated
June 6, 2019
Sponsor
AORTICA Group
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1. Study Identification

Unique Protocol Identification Number
NCT03435133
Brief Title
Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI
Acronym
COMPARE
Official Title
Comparison of Prasugrel vs. Ticagrelor on Myocardial Injury in Revascularized ST Elevation Acute Myocardial Infarction Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AORTICA Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
Primary angioplasty, Prasugrel, Ticagrelor, STEMI, cardiac magnetic resonance, infarct size, infarct injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel
Arm Type
Active Comparator
Arm Title
Ticagrelor
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
60 mg oral bolus plus oral 10 mg once daily
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
180 mg oral bolus plus oral 90 mg every 12 hours daily
Primary Outcome Measure Information:
Title
Infarct size
Description
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Infarct size
Description
Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)
Time Frame
up to two weeks
Title
Myocardial salvage index
Description
Cardiac magnetic resonance imaging-assessed myocardial salvage index
Time Frame
up to two weeks
Title
Microvascular obstruction
Description
Cardiac magnetic resonance imaging-assessed microvascular obstruction
Time Frame
up to two weeks
Title
MACE
Description
The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro L Sanchez, MD, PhD
Organizational Affiliation
Hospital Universitario Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pedro Dorado
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

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Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI

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