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

ST-Elevation Myocardial Infarction Clinical Trial

— RESET 2D  

Official title:

Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531114
• Other study ID #: RESET 2D Trial
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2012
• Last updated: June 27, 2017
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: June 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Infarction
• Myocardial Infarction
• ST-Elevation Myocardial Infarction

Intervention

Drug:
• ticagrelor
Patients will be randomized to this arm to receive loading dose of ticagrelor
• prasugrel
Patients will be randomized to this arm to receive loading dose of prasugrel

Locations

Country	Name	City	State
Italy	Dept.of Cardiovascular Sciences,Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Gennaro Sardella

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PR level measured at 6 and 12 hours post study drugs administration.		in hospital