PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus

NCT ID: NCT01531114

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-07-31

Brief Summary

Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.

Conditions

ST-Elevation Myocardial Infarction

Study Design

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

Study Groups

Prasugrel loading dose

Patients will be randomized to this arm to receive loading dose of prasugrel

Group Type: ACTIVE_COMPARATOR

ticagrelor

Intervention Type: DRUG

Patients will be randomized to this arm to receive loading dose of ticagrelor

prasugrel

Intervention Type: DRUG

Patients will be randomized to this arm to receive loading dose of prasugrel

ticagrelor loading dose

Patients will be randomized to this arm to receive loading dose of ticagrelor

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ticagrelor

Patients will be randomized to this arm to receive loading dose of ticagrelor

Intervention Type: DRUG

prasugrel

Patients will be randomized to this arm to receive loading dose of prasugrel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diabetic patients
• acute coronary syndrome
• patients underwent to primary PCI
• naïve for platelet P2Y12 receptor inhibition therapy

Exclusion Criteria

• history of bleeding diathesis
• chronic oral anticoagulation treatment
• contraindications to antiplatelet therapy
• PCI or coronary artery bypass grafting (CABG) < 3 months
• hemodynamic instability
• platelet count < 100,000/μl
• hematocrit < 30%
• creatinine clearance < 25 ml/min
• Patients with a history of stroke
• contraindication for prasugrel administration
• patients weighing < 60 kg
• patients treated with morphine
• > 75 years of age.

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

Sponsors

Gennaro Sardella

OTHER

Sponsor Role: lead

Responsible Party

Gennaro Sardella

Associate Professor in Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, , Italy

Countries

Italy

Other Identifiers

RESET 2D Trial

Identifier Type: -

Identifier Source: org_study_id