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

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

Study Overview

• Status: Completed
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Prasugrel; Drug: Ticagrelor

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Pedro Dorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct size	Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct size	Cardiac magnetic resonance imaging-assessed infarct size of left ventricular mass (%)	up to two weeks
Myocardial salvage index	Cardiac magnetic resonance imaging-assessed myocardial salvage index	up to two weeks
Microvascular obstruction	Cardiac magnetic resonance imaging-assessed microvascular obstruction	up to two weeks
MACE	The rate of MACE defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization	6 months

Collaborators and Investigators

• Sponsor: AORTICA Group
• Investigators: Principal Investigator: Pedro L Sanchez, MD, PhD, Hospital Universitario Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2015
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Ticagrelor; STEMI; Prasugrel; cardiac magnetic resonance; infarct size; Primary angioplasty; infarct injury
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Prasugrel Hydrochloride
• Other Study ID Numbers: CARDIO2015.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No