Rapid Activity of Platelet Inhibitor Drugs Study 2

NCT ID: NCT01805570

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-04-30

Brief Summary

The aim of the RAPID study is to evaluate the superiority rapid onset of action of Ticagrelor 360 mg LD versus Prasugrel 60 mg LD, in 50 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI with bivalirudin monotherapy. Secondary study aim is to found out clinical predictors of high residual platelet reactivity in the first hour after a novel oral antiplatelet agent LD.

Detailed Description

50 consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel (n= 25) or Ticagrelor (n= 25) before PPCI ( primary percutaneous coronary intervention) in a open label fashion. The loading dose of Prasugrel will be 60 mg, the loading dose of Ticagrelor will be 360 mg in 25 patients. 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 first hour after drug loading dose a new reduced loading dose will be administered (30 mg Prasugrel or 180 mg Ticagrelor). 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 (percutaneous coronary intervention) 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 LD), and after 1, 2, 4 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, Aspirin Reactivity Units (ARU) by VerifyNow will be also assessed. Follow-up will be performed by outpatient visits or telephone interviews at 6 months.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prasugrel loading dose

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI.

Group Type: ACTIVE_COMPARATOR

Prasugrel

Intervention Type: DRUG

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI. The loading dose of Prasugrel will be 60 mg. 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 first hour after drug loading dose a new reduced loading dose will be administered .

Ticagrelor loading dose

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI.

Group Type: ACTIVE_COMPARATOR

Ticagrelor

Intervention Type: DRUG

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI. The loading dose of Ticagrelor will be 360 mg. 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 first hour after drug loading dose a new reduced loading dose will be administered .

Interventions

Prasugrel

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI. The loading dose of Prasugrel will be 60 mg. 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 first hour after drug loading dose a new reduced loading dose will be administered .

Intervention Type: DRUG

Ticagrelor

25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI. The loading dose of Ticagrelor will be 360 mg. 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 first hour after drug loading dose a new reduced loading dose will be administered .

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients presenting within 12 hours from the onset of symptoms with STEMI (ST segment elevation myocardial infarction)
• Informed, written consent

Exclusion Criteria

• Age < 18 years or Age > 75 years
• Active bleeding; bleeding diathesis; coagulopathy
• Increased risk of bradycardiac events
• History of gastrointestinal or genitourinary bleeding <2 months
• Major surgery in the last 6 weeks
• History of intracranial bleeding or structural abnormalities
• Suspected aortic dissection
• Any previous TIA (transient ischemic attack)/stroke
• Any other condition that may put the patient at risk or influence study results or investigator's opinion (severe haemodynamic instability, known malignancies or other comorbid conditions with life expectancy <1 year)
• Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
• Concomitant oral or IV therapy with strong CYP3A inhibitors or strong CYP3A inducers, CYP3A with narrow therapeutic windows
• Known relevant hematological deviations: Hb <10 g/dl, Platelet count <100x10^9/l
• Use of coumadin derivatives within the last 7 days
• Chronic therapy with prasugrel or ticagrelor
• Known severe liver disease, severe renal failure
• Known allergy to the study medications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

A.R. CARD Onlus Foundation

OTHER

Sponsor Role: collaborator

David Antoniucci

OTHER

Sponsor Role: lead

Responsible Party

David Antoniucci

Head Division of Invasive Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Antoniucci, MD

Role: PRINCIPAL_INVESTIGATOR

Careggi Hospital, Division of Invasive Cardiology

Locations

Careggi Hospital

Florence, , Italy

Countries

Italy

References

Parodi G, Bellandi B, Valenti R, Migliorini A, Marcucci R, Carrabba N, Giurlani L, Gensini GF, Abbate R, Antoniucci D. Comparison of double (360 mg) ticagrelor loading dose with standard (60 mg) prasugrel loading dose in ST-elevation myocardial infarction patients: the Rapid Activity of Platelet Inhibitor Drugs (RAPID) primary PCI 2 study. Am Heart J. 2014 Jun;167(6):909-14. doi: 10.1016/j.ahj.2014.03.011. Epub 2014 Apr 4.

Reference Type: DERIVED

PMID: 24890542 (View on PubMed)

Other Identifiers

RAPID STUDY 2

Identifier Type: -

Identifier Source: org_study_id