Status:
COMPLETED
Rapid Activity of Platelet Inhibitor Drugs Study
Lead Sponsor:
Careggi Hospital
Conditions:
ST-segment Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with bivalirudin monother...
Detailed Description
Fifty consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be randomized to receive 60 mg Prasugrel loading dose (n= 25) or 180 Ticagrelor loading dose (n= ...
Eligibility Criteria
Inclusion
- Patients presenting within 12 hours from the onset of symptoms with STEMI
- Informed, written consent
Exclusion
- Age \< 18 years
- Active bleeding; bleeding diathesis; coagulopathy
- 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/stroke
- Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, GPI.
- 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 malignancies or other comorbid conditions with life expectancy \<1 year
- Known severe liver disease, severe renal failure
- Known allergy to the study medications
- Pregnancy
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01510171
Start Date
January 1 2012
End Date
January 1 2013
Last Update
September 25 2014
Active Locations (1)
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1
Careggi Hospital
Florence, Italy, 50134