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PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus (RESET I-2D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gennaro Sardella, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01531114
First received: February 7, 2012
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
ST-Elevation Myocardial Infarction
Drug: ticagrelor
Drug: prasugrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Prasugrel Or Ticagrelor In ST-Elevation Myocardial InfarcTion Patients With Diabetes Mellitus Requiring or Not Insulin Treatment.

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • PR level measured at 6 and 12 hours post study drugs administration. [ Time Frame: in hospital ]

Enrollment: 50
Study Start Date: May 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel loading dose
Patients will be randomized to this arm to receive loading dose of prasugrel
Drug: ticagrelor
Patients will be randomized to this arm to receive loading dose of ticagrelor
Drug: prasugrel
Patients will be randomized to this arm to receive loading dose of prasugrel
No Intervention: ticagrelor loading dose
Patients will be randomized to this arm to receive loading dose of ticagrelor

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531114

Locations
Italy
Dept.of Cardiovascular Sciences,Policlinico Umberto I
Rome, Italy, 00161
Sponsors and Collaborators
Gennaro Sardella
  More Information

Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01531114     History of Changes
Other Study ID Numbers: RESET I-2D Trial
Study First Received: February 7, 2012
Last Updated: January 31, 2017

Keywords provided by University of Roma La Sapienza:
Diabetes mellitus
antiplatelet effect
prasugrel
ticagrelor
STEMI
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Infarction
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Prasugrel Hydrochloride
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on March 24, 2017