Prasugrel vs. Ticagrelor on Myocardial Injury in STEMI

NCT ID: NCT03435133

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-23
• Study Completion Date: 2018-12-31

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.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prasugrel

Group Type: ACTIVE_COMPARATOR

Prasugrel

Intervention Type: DRUG

60 mg oral bolus plus oral 10 mg once daily

Ticagrelor

Group Type: ACTIVE_COMPARATOR

Ticagrelor

Intervention Type: DRUG

180 mg oral bolus plus oral 90 mg every 12 hours daily

Interventions

Prasugrel

60 mg oral bolus plus oral 10 mg once daily

Intervention Type: DRUG

Ticagrelor

180 mg oral bolus plus oral 90 mg every 12 hours daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AORTICA Group

OTHER

Sponsor Role: lead

Responsible Party

Pedro L Sanchez

Head of Cardiology, PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro L Sanchez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Salamanca

Locations

Pedro Dorado

Salamanca, , Spain

Countries

Spain

Other Identifiers

CARDIO2015.1

Identifier Type: -

Identifier Source: org_study_id