Status:
COMPLETED
Rapid Activity of Platelet Inhibitor Drugs Study 2
Lead Sponsor:
David Antoniucci
Collaborating Sponsors:
A.R. CARD Onlus Foundation
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
50 consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel (n= 25) or Ticagrelor (n= 25) before PPCI ( primary percutaneous c...
Eligibility Criteria
Inclusion
- Patients presenting within 12 hours from the onset of symptoms with STEMI (ST segment elevation myocardial infarction)
- Informed, written consent
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01805570
Start Date
November 1 2012
End Date
April 1 2013
Last Update
September 25 2014
Active Locations (1)
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1
Careggi Hospital
Florence, Italy