Overview

Rapid Activity of Platelet Inhibitor Drugs Study

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
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 monotherapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Careggi Hospital
Treatments:
Platelet Aggregation Inhibitors
Prasugrel Hydrochloride
Ticagrelor
Criteria
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