Clinical trial NCT01510171: Rapid Activity of Platelet Inhibitor Drugs Study
Official title: Rapid Activity of Platelet Inhibitor Drugs Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: platelet inhibitor
ST-segment elevation myocardial infarction
stent
prasugrel
ticagrelor
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Residual platelet reactivity by VerifyNow
timeFrame: 2 hours
Secondary outcomes:
measure: High residual platelet reactivity
timeFrame: 2,4,8,12 hours
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi Hospital
Study officials:
affiliation: Careggi Hospital, Division of Invasive Cardiology
name: David Antoniucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22.