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BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)

This study has been terminated.
(Low events rate. Scarce economical resources)
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: July 28, 2016
Last verified: July 2016

February 12, 2013
July 28, 2016
November 2012
October 2014   (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 Consortium criteria (11), occurring from 1 month to the end of the study.
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.
Complete list of historical versions of study NCT01790854 on ClinicalTrials.gov Archive Site
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.
 
Terminated
195
October 2014
October 2014   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01790854
BLESS Study
Yes
Not Provided
Not Provided
David Antoniucci, Careggi Hospital
David Antoniucci
A.R. CARD Onlus Foundation
Principal Investigator: David Antoniucci, MD Careggi Hospital, division of Invasive Cardiology
Careggi Hospital
July 2016

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