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

Phase 3

Completed

• Conditions: ST-Elevation Myocardial Infarction
• Interventions: Drug: ticagrelor; Drug: prasugrel

• Registration Number: NCT01531114
• Lead Sponsor: Gennaro Sardella

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2013-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel loading dose	prasugrel	Patients will be randomized to this arm to receive loading dose of prasugrel
Prasugrel loading dose	ticagrelor	Patients will be randomized to this arm to receive loading dose of prasugrel

Primary Outcome Measures

Name	Time	Method
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 2 hours post drug administration.	1 and 2 hours

Secondary Outcome Measures

Name	Time	Method
PR level measured at 6 and 12 hours post study drugs administration.	in hospital

Trial Locations

Locations (1)

Dept.of Cardiovascular Sciences,Policlinico Umberto I; 🇮🇹 Rome, Italy