Rapid Activity of Platelet Inhibitor Drugs Study (RAPID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01510171
First received: January 11, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
ST-segment Elevation Myocardial Infarction
Drug: Prasugrel
Drug: Ticagrelor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapid Activity of Platelet Inhibitor Drugs Study

Resource links provided by NLM:


Further study details as provided by Careggi Hospital:

Primary Outcome Measures:
  • Residual platelet reactivity by VerifyNow [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    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:
  • High residual platelet reactivity [ Time Frame: 2,4,8,12 hours ] [ Designated as safety issue: Yes ]
    High residual platelet reactivity will be defined as a Platelet Reactivity Units (PRU) > 240 by VerifyNow.


Enrollment: 50
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel loading dose 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.
Active Comparator: Ticagrelor Loading dose 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510171

Locations
Italy
Careggi Hospital
Florence, Italy, 50134
Sponsors and Collaborators
Careggi Hospital
Investigators
Principal Investigator: David Antoniucci, MD Careggi Hospital, Division of Invasive Cardiology
  More Information

No publications provided by Careggi Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Antoniucci, Head Division of Invasive Cardiology, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01510171     History of Changes
Other Study ID Numbers: RAPID
Study First Received: January 11, 2012
Last Updated: September 24, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Careggi Hospital:
platelet inhibitor
ST-segment elevation myocardial infarction
stent
prasugrel
ticagrelor

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Ticagrelor
Prasugrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014