PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in Acute Coronary Syndrome paTients With Diabetes Mellitus (RESET 2D)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Gennaro Sardella, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01531114
First received: February 7, 2012
Last updated: April 19, 2013
Last verified: April 2013

February 7, 2012
April 19, 2013
May 2013
August 2013   (final data collection date for primary outcome measure)
The non-inferiority antiplatelet effect in terms of level platelet reactivity (< 240 PRU) of loading dose of prasugrel (60 mg) versus loading dose of Ticagrelor (180 mg) in patients undergoing PPCI at 6 hours from the administration of the drug. [ Time Frame: 6 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
Bleeding (major, minor, or minimal according to the TIMI study criteria) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Bleeding (major, minor, or minimal according to the TIMI study criteria)
  • 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
major adverse cardiac events (cardiovascular death, myocardial infarction, stroke, stent thrombosis) [ Time Frame: in hospital ] [ Designated as safety issue: Yes ]
Not Provided
 
PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in Acute Coronary Syndrome paTients With Diabetes Mellitus
PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in Acute Coronary Syndrome paTients With Diabetes Mellitus.RESET 2D Trial

Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) with percutaneous coronary intervention (PCI) and drug eluting stent(s) implantation. Current guidelines recommend prasugrel and ticagrelor in patients with ACS undergoing primary percutaneous coronary intervention (PPCI). We sought to investigate the non-inferiority antiplatelet effect in terms of level platelet reactivity (< 240 PRU) of loading dose of prasugrel (60 mg) versus loading dose of Ticagrelor (180 mg) in patients undergoing PPCI at 6 hours from the administration of the drug (primary end-point). Secondary end-points will be in hospital NACE (cardiovascular death, myocardial infarction, stroke and bleedings according to the TIMI criteria), stent thrombosis in overall population. All consecutive diabetic patients with acute coronary syndrome (ACS) 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: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
  • 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.
 
Not yet recruiting
30
August 2013
August 2013   (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
  • > 75 years of age.
Both
18 Years to 75 Years
No
Contact: Gennaro Sardella, MD +390649979035 rino.sardella@uniroma1.it
Italy
 
NCT01531114
RESET 2D
Yes
Gennaro Sardella, University of Roma La Sapienza
Gennaro Sardella
Not Provided
Not Provided
University of Roma La Sapienza
April 2013

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