Rapid Activity of Platelet Inhibitor Drugs Study 2
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Prasugrel
Ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring platelet inhibitor, ST-segment Elevation, Myocardial Infarction, stent, prasugrel, ticagrelor
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
Sites / Locations
- Careggi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prasugrel loading dose
Ticagrelor loading dose
Arm Description
25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI.
25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI.
Outcomes
Primary Outcome Measures
Residual Platelet Reactivity by VerifyNow
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after oral antiplatelet agent LD.
Secondary Outcome Measures
High residual platelet reactivity
High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow
Full Information
NCT ID
NCT01805570
First Posted
March 5, 2013
Last Updated
September 24, 2014
Sponsor
David Antoniucci
Collaborators
A.R. CARD Onlus Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01805570
Brief Title
Rapid Activity of Platelet Inhibitor Drugs Study 2
Official Title
Rapid Activity of Platelet Inhibitor Drugs Study (RAPID 2)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Antoniucci
Collaborators
A.R. CARD Onlus Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
platelet inhibitor, ST-segment Elevation, Myocardial Infarction, stent, prasugrel, ticagrelor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prasugrel loading dose
Arm Type
Active Comparator
Arm Description
25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI.
Arm Title
Ticagrelor loading dose
Arm Type
Active Comparator
Arm Description
25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI.
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
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
Intervention Name(s)
Ticagrelor
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Residual Platelet Reactivity by VerifyNow
Description
residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after oral antiplatelet agent LD.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
High residual platelet reactivity
Description
High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow
Time Frame
2,4,12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Antoniucci, MD
Organizational Affiliation
Careggi Hospital, Division of Invasive Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Careggi Hospital
City
Florence
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24890542
Citation
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.
Results Reference
derived
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Rapid Activity of Platelet Inhibitor Drugs Study 2
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