Rapid Activity of Platelet Inhibitor Drugs Study

Phase 4

Completed

• Conditions: ST-segment Elevation Myocardial Infarction
• Interventions: Drug: Prasugrel; Drug: Ticagrelor

• Registration Number: NCT01510171
• Lead Sponsor: Careggi Hospital

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-13
• Primary Completion: 2012-06
• Study Completion: 2013-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel loading dose	Prasugrel	-
Ticagrelor Loading dose	Ticagrelor	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Careggi Hospital; 🇮🇹 Florence, Italy