BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Careggi Hospital
Sponsor:
Collaborator:
A.R. CARD Onlus Foundation
Information provided by (Responsible Party):
David Antoniucci, Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01790854
First received: February 12, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

Aim: to verify if after the acute phase of ACS acute coronary syndrome (1-months), from 1 to 12 months the reduction of maintenance dose of prasugrel from 10 mg to 5 mg/day may reduce the bleeding events (5 mg vs 10 mg). All patients will be treated with 325 mg of aspirin followed by a maintenance dosage of 100 mg of aspirin for at least 1 year. At baseline (after 60 mg loading dose of prasugrel) and after 1 month (7 days after the randomization at 10 or 5 mg of prasugrel) all patients will undergo light transmittance aggregometry (LTA) test to evaluate residual platelet reactivity (pharmacodynamic effects).


Condition Intervention Phase
Adverse Reaction to Antiplatelet Agent
Acute Coronary Syndrome
Drug: Prasugrel dose 5 mg/day
Drug: Prasugrel dose 10 mg/day
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)

Resource links provided by NLM:


Further study details as provided by Careggi Hospital:

Primary Outcome Measures:
  • bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consurtium criteria (11), occurring from 1 month to the end of the study.


Secondary Outcome Measures:
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.


Other Outcome Measures:
  • pharmacodynamic effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    pharmacodynamic effects of shifting prasugrel maintenance dose from 10 mg to 5 mg after ACS

  • residual platelet reactivity (LTA) [ Time Frame: baseline - 1 month ] [ Designated as safety issue: Yes ]
    correlation between residual platelet reactivity (LTA), both at baseline and at 1-month, with bleeding and ischemic events


Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel dose 5 mg/day
225 patients will be treated with 325 mg of aspirin (followed by a maintenance dosage of 100 mg of aspirin for at least 1 year and with 60 mg loading dose of prasugrel followed by a maintenance dosage of 5 mg/day of prasugrel for 12 months
Drug: Prasugrel dose 5 mg/day
Active Comparator: Prasugrel dose 10 mg/day
225 patients will be treated with 325 mg of aspirin (followed by a maintenance dosage of 100 mg of aspirin for at least 1 year and with 60 mg loading dose of prasugrel followed by a maintenance dosage of 10 mg/day of prasugrel for 12 months
Drug: Prasugrel dose 10 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all ACS patients treated with PCI (percutaneous coronary intervention) and dual antiplatelet therapy (DAPT: aspirin plus prasugrel).
  • Informed written consent

Exclusion Criteria:

  • Age < 18 years
  • Active bleeding; bleeding diathesis; coagulopathy
  • 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
  • Administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux .
  • Known relevant hematological deviations: Hb <10 g/dl, Thrombocytopenia. <100x10^9/l
  • Use of coumadin derivatives within the last 7 days
  • Chronic therapy with prasugrel or ticagrelor
  • Known malignancies or other comorbid conditions with life expectancy <1 year
  • Known severe liver disease, severe renal failure
  • Known allergy to the study medications
  • 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: NCT01790854

Contacts
Contact: David Antoniucci, MD +390557947966 david.antoniucci@virgilio.it
Contact: Nazario Carrabba, MD +390557947966 n.carrabba@virgilio.it

Locations
Italy
Careggi Hospital Recruiting
Florence, Italy
Contact: David Antoniucci, MD    +390557947966    david.antoniucci@virgilio.it   
Contact: Nazario Carrabba, MD    +390557947966    n.carrabba@virgilio.it   
Principal Investigator: David Antoniucci, MD         
Sponsors and Collaborators
David Antoniucci
A.R. CARD Onlus Foundation
Investigators
Principal Investigator: David Antoniucci, MD Careggi Hospital, division of Invasive Cardiology
  More Information

No publications provided

Responsible Party: David Antoniucci, Head Division of Invasive Cardiology, Careggi Hospital
ClinicalTrials.gov Identifier: NCT01790854     History of Changes
Other Study ID Numbers: BLESS Study
Study First Received: February 12, 2013
Last Updated: February 12, 2013
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Careggi Hospital:
prasugrel
antiplatelet
Acute Coronary Syndrome

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Prasugrel
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

ClinicalTrials.gov processed this record on September 18, 2014