ST-segment Elevation Myocardial Infarction
Conditions
Keywords
platelet inhibitor, ST-segment elevation myocardial infarction, stent, prasugrel, ticagrelor
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 monotherapy.
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= 25) before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered. All interventions will be performed by the femoral approach according to current standards. The use of thrombectomy before infarct-related artery stenting, of everolimus eluting stent and of closure devices will be strongly encouraged. Bivalirudin will be administered as a bolus 0.75 mg/kg followed by 1.75 mg/kg/h infusion during PCI. After PCI a reduced bivalirudin infusion of 0.25 mg/kg/h for 4 hours will be allowed. Dual antiplatelet therapy (100 mg aspirin associated with 5 or 10 mg Prasugrel or 180 mg Ticagrelor) will be recommended for 12 months. Residual platelet reactivity will be assessed in all patients at baseline (time of loading dose), and after 2, 4, 8 and 12 hours by a point-of-care test VerifyNow bedside available in the Intensive cardiac care Unit. High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) \> 240 by VerifyNow. At the same time point, Activated Clotting Time (ACT) will be also assessed. Follow-up will be performed by outpatient visits or telephone interviews at 6 months.
Interventions
DRUGPrasugrel
25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 60 mg Prasugrel loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.
DRUGTicagrelor
25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 180 Ticagrelor loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.
Sponsors
Careggi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual platelet reactivity by VerifyNow | 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High residual platelet reactivity | 2,4,8,12 hours | High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) \> 240 by VerifyNow. |
Countries
Italy
Outcome results
None listed