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

February 7, 2012
August 8, 2016
May 2013
July 2015   (final data collection date for primary outcome measure)
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 ]
antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable and diabetic patients with HTPR [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ]
The primary aim will be to investigate the antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable and diabetic patients with HTPR while receiving chronic clopidogrel treatment at the end of the 2 study periods (switching, crossover and post-crossover)
Complete list of historical versions of study NCT01531114 on ClinicalTrials.gov Archive Site
PR level measured at 6 and 12 hours post study drugs administration. [ Time Frame: in hospital ] [ Designated as safety issue: Yes ]
  • Bleeding (major, minor, or minimal according to the TIMI study criteria) [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ]
    Bleeding (major, minor, or minimal according to the TIMI study criteria)
  • Major Adverse Cardiac Cerebrovascular Events [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ]
    cardiovascular death, myocardial infarction, and stroke
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 ]
Not Provided
 
PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus
PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus. RESET 2D Trial
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ST-Elevation Myocardial Infarction
  • 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
  • Active Comparator: Prasugrel loading dose
    Patients will be randomized to this arm to receive loading dose of prasugrel
    Interventions:
    • Drug: ticagrelor
    • Drug: prasugrel
  • No Intervention: ticagrelor loading dose
    Patients will be randomized to this arm to receive loading dose of ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01531114
RESET 2D
Yes
Not Provided
Not Provided
Gennaro Sardella, University of Roma La Sapienza
Gennaro Sardella
Not Provided
Not Provided
University of Roma La Sapienza
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP