ST-segment Elevation Myocardial Infarction Clinical Trial
— RAPIDOfficial title:
Rapid Activity of Platelet Inhibitor Drugs Study
Verified date | September 2014 |
Source | Careggi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Interventional |
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 monotherapy.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 2013 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients presenting within 12 hours from the onset of symptoms with STEMI 2. Informed, written consent Exclusion Criteria: 1. Age < 18 years 2. Active bleeding; bleeding diathesis; coagulopathy 3. History of gastrointestinal or genitourinary bleeding <2 months 4. Major surgery in the last 6 weeks 5. History of intracranial bleeding or structural abnormalities 6. Suspected aortic dissection 7. Any previous TIA/stroke 8. Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux, GPI. 9. Known relevant hematological deviations: Hb <10 g/dl, Platelet count <100x10^9/l 10. Use of coumadin derivatives within the last 7 days 11. Chronic therapy with prasugrel or ticagrelor 12. Known malignancies or other comorbid conditions with life expectancy <1 year 13. Known severe liver disease, severe renal failure 14. Known allergy to the study medications 15. Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Careggi Hospital | Florence |
Lead Sponsor | Collaborator |
---|---|
Careggi Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Residual platelet reactivity by VerifyNow | Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit. | 2 hours | Yes |
Secondary | High residual platelet reactivity | High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow. | 2,4,8,12 hours | Yes |
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