PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in Acute Coronary Syndrome paTients With Diabetes Mellitus
Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome
Intervention: ticagrelor (Drug); prasugrel (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Gennaro Sardella Overall contact: Gennaro Sardella, MD, Phone: +390649979035, Email: rino.sardella@uniroma1.it
Summary
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.
Clinical Details
Official title: PhaRmacodynamic Effect of Therapy With PraSugrel or TicagrElor in Acute Coronary Syndrome paTients With Diabetes Mellitus.RESET 2D Trial
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Bleeding (major, minor, or minimal according to the TIMI study criteria)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Gennaro Sardella, MD, Phone: +390649979035, Email: rino.sardella@uniroma1.it
Dept.of Cardiovascular Sciences,Policlinico Umberto I, Rome 00161, Italy; Recruiting Simone Calcagno, MD, Phone: +390649979044, Email: calcagnosimone@libero.it Massimo Mancone, MD, Phone: +390649979044, Email: massimomancone@gmail.com Simone Calcagno, MD, Sub-Investigator Masismo MANCONE, MD, Sub-Investigator MAURO PENNACCHI, MD, Sub-Investigator
Additional Information
Starting date: May 2013
Last updated: April 19, 2013
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