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PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus (RESET 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: June 27, 2017
Last verified: June 2017
February 7, 2012
June 27, 2017
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: 1 and 2 hours ]
antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable and diabetic patients with HTPR [ Time Frame: 14-28 days ]
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 ]
  • Bleeding (major, minor, or minimal according to the TIMI study criteria) [ Time Frame: 14-28 days ]
    Bleeding (major, minor, or minimal according to the TIMI study criteria)
  • Major Adverse Cardiac Cerebrovascular Events [ Time Frame: 14-28 days ]
    cardiovascular death, myocardial infarction, and stroke
Not Provided
Not Provided
 
PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus
Prasugrel Or 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
50
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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01531114
RESET 2D Trial
Yes
Not Provided
Not Provided
Gennaro Sardella, University of Roma La Sapienza
Gennaro Sardella
Not Provided
Not Provided
University of Roma La Sapienza
June 2017

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