BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)

This study is currently recruiting participants.
Verified February 2013 by Careggi Hospital
Sponsor:
Collaborator:
ARCARD 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

February 12, 2013
February 12, 2013
November 2012
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
  • 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
Same as current
 
BLeeding Events and Maintenance DoSe of PraSugrel
Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adverse Reaction to Antiplatelet Agent
  • Acute Coronary Syndrome
  • Drug: Prasugrel dose 5 mg/day
  • Drug: Prasugrel dose 10 mg/day
  • 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
    Intervention: 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
    Intervention: Drug: Prasugrel dose 10 mg/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
October 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
No
Contact: David Antoniucci, MD +390557947966 david.antoniucci@virgilio.it
Contact: Nazario Carrabba, MD +390557947966 n.carrabba@virgilio.it
Italy
 
NCT01790854
BLESS Study
Yes
David Antoniucci, Careggi Hospital
David Antoniucci
ARCARD ONLUS Foundation
Principal Investigator: David Antoniucci, MD Careggi Hospital, division of Invasive Cardiology
Careggi Hospital
February 2013

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