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Completed

NCT Number: NCT01531114

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

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.

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Key information

Conditions

ST-elevation Myocardial Infarction Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hyperinsulinism Infarction Insulin Resistance Ischemia Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ticagrelor

Drug

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

Prasugrel

Drug

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

Primary outcomes

  1. 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.

    Time frame: 1 and 2 hours

Secondary outcomes

  1. PR level measured at 6 and 12 hours post study drugs administration.

    Time frame: in hospital

Sponsors and collaborators

Lead sponsor

Gennaro Sardella

Other

Registry information

Official study title

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

Acronym: RESET 2D

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2012
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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