Rapid Activity of Platelet Inhibitor Drugs Study 2

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the RAPID study is to evaluate the superiority rapid onset of action of Ticagrelor 360 mg LD versus Prasugrel 60 mg LD, in 50 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI with bivalirudin monotherapy. Secondary study aim is to found out clinical predictors of high residual platelet reactivity in the first hour after a novel oral antiplatelet agent LD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Antoniucci
• Collaborator: A.R. CARD Onlus Foundation
• Treatments: Bivalirudin; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

• Patients presenting within 12 hours from the onset of symptoms with STEMI (ST segment elevation myocardial infarction)

• Informed, written consent

Exclusion Criteria:

• Age < 18 years or Age > 75 years

• Active bleeding; bleeding diathesis; coagulopathy

• Increased risk of bradycardiac events

• History of gastrointestinal or genitourinary bleeding <2 months

• Major surgery in the last 6 weeks

• History of intracranial bleeding or structural abnormalities

• Suspected aortic dissection

• Any previous TIA (transient ischemic attack)/stroke

• Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe haemodynamic instability, known malignancies or other comorbid conditions with life expectancy <1 year)

• Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .

• Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows

• Known relevant hematological deviations: Hb <10 g/dl, Platelet count <100x10^9/l

• Use of coumadin derivatives within the last 7 days

• Chronic therapy with prasugrel or ticagrelor

• Known severe liver disease, severe renal failure

• Known allergy to the study medications