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Rapid Activity of Platelet Inhibitor Drugs Study (RAPID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510171
First Posted: January 13, 2012
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
January 11, 2012
January 13, 2012
September 25, 2014
January 2012
June 2012   (Final data collection date for primary outcome measure)
Residual platelet reactivity by VerifyNow [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01510171 on ClinicalTrials.gov Archive Site
High residual platelet reactivity [ Time Frame: 2,4,8,12 hours ]
High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow.
Same as current
Not Provided
Not Provided
 
Rapid Activity of Platelet Inhibitor Drugs Study
Rapid Activity of Platelet Inhibitor Drugs Study
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
ST-segment Elevation Myocardial Infarction
  • Drug: Prasugrel
    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.
  • Drug: Ticagrelor
    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.
  • Active Comparator: Prasugrel loading dose
    Intervention: Drug: Prasugrel
  • Active Comparator: Ticagrelor Loading dose
    Intervention: Drug: Ticagrelor
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2013
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01510171
RAPID
Yes
Not Provided
Not Provided
David Antoniucci, Careggi Hospital
Careggi Hospital
Not Provided
Principal Investigator: David Antoniucci, MD Careggi Hospital, Division of Invasive Cardiology
Careggi Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP