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
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: ticagrelor
Drug: prasugrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in Acute Coronary Syndrome 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 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 ]

Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • major adverse cardiac events (cardiovascular death, myocardial infarction, stroke, stent thrombosis) [ Time Frame: in hospital ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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
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
  • > 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

Contacts
Contact: Gennaro Sardella, MD +390649979035 rino.sardella@uniroma1.it

Locations
Italy
Dept.of Cardiovascular Sciences,Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Simone Calcagno, MD    +390649979044    calcagnosimone@libero.it   
Contact: Massimo Mancone, MD    +390649979044    massimomancone@gmail.com   
Sub-Investigator: Simone Calcagno, MD         
Sub-Investigator: Masismo MANCONE, MD         
Sub-Investigator: MAURO PENNACCHI, MD         
Sponsors and Collaborators
Gennaro Sardella
  More Information

No publications provided

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: April 19, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Diabetes mellitus
antiplatelet effect
prasugrel
ticagrelor
acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Diabetes Mellitus
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Prasugrel
Ticagrelor
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on October 23, 2014