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PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus (RESET2D)

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: August 8, 2016
Last verified: August 2016
  Purpose
Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year 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 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital and the incidence of NACE (cardiovascular death, myocardial infarction, stroke and bleedings according to the TIMI criteria), stent thrombosis in overall population. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 2-6-12 h after the drug loading dose administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus. RESET 2D Trial

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: 2 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PR level measured at 6 and 12 hours post study drugs administration. [ Time Frame: in hospital ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • The incidence of in-hospital events (cardiovascular death, myocardial infarction, stroke and bleedings according to the TIMI criteria) and stent thrombosis in overall population. [ Time Frame: in hospital ] [ Designated as safety issue: Yes ]

Enrollment: 42
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)
Genders Eligible for Study:   Both
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 2D 
Study First Received: February 7, 2012
Last Updated: August 8, 2016
Health Authority: Italy: Ethics Committee

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

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 December 02, 2016