BLeeding Events and Maintenance DoSe of PraSugrel

Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790854

Acronym

BLESS

Enrollment

195

Registered

2013-02-13

Start date

2012-11-30

Completion date

2014-10-31

Last updated

2016-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent

Keywords

prasugrel, antiplatelet, Acute Coronary Syndrome

Brief summary

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).

Interventions

DRUGPrasugrel dose 5 mg/day

DRUGPrasugrel dose 10 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

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

Design outcomes

Primary

Measure	Time frame	Description
bleeding	12 months	major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consortium criteria (11), occurring from 1 month to the end of the study.

Secondary

Measure	Time frame	Description
MACE	12 months	MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.

Other

Measure	Time frame	Description
pharmacodynamic effects	12 months	pharmacodynamic effects of shifting prasugrel maintenance dose from 10 mg to 5 mg after ACS
residual platelet reactivity (LTA)	baseline - 1 month	correlation between residual platelet reactivity (LTA), both at baseline and at 1-month, with bleeding and ischemic events

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026