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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

Page last updated: August 20, 2015

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