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BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)

D

David Antoniucci

Status and phase

Terminated
Phase 4

Conditions

Acute Coronary Syndrome
Adverse Reaction to Antiplatelet Agent

Treatments

Drug: Prasugrel dose 10 mg/day
Drug: Prasugrel dose 5 mg/day

Study type

Interventional

Funder types

Other

Identifiers

NCT01790854
BLESS Study

Details and patient eligibility

About

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).

Enrollment

195 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

195 participants in 2 patient groups

Prasugrel dose 5 mg/day
Experimental group
Description:
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
Treatment:
Drug: Prasugrel dose 5 mg/day
Prasugrel dose 10 mg/day
Active Comparator group
Description:
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
Treatment:
Drug: Prasugrel dose 10 mg/day

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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