Clinical trial NCT01790854: BLeeding Events and Maintenance DoSe of PraSugrel
Official title: Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Adverse Reaction to Antiplatelet Agent
Acute Coronary Syndrome
Keywords: prasugrel
antiplatelet
Acute Coronary Syndrome
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
Collaborators: name: A.R. CARD Onlus Foundation
First posted: 2013-02-13
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: bleeding
timeFrame: 12 months
Secondary outcomes:
measure: MACE
timeFrame: 12 months
Other outcomes:
measure: pharmacodynamic effects
timeFrame: 12 months
measure: residual platelet reactivity (LTA)
timeFrame: baseline - 1 month
Locations:
city: Florence
country: Italy
facility: Careggi Hospital
Study officials:
affiliation: Careggi Hospital, division of Invasive Cardiology
name: David Antoniucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrabba N, Parodi G, Marcucci R, Valenti R, Gori AM, Migliorini A, Comito V, Bellandi B, Abbate R, Gensini GF, Antoniucci D. Bleeding events and maintenance dose of prasugrel: BLESS pilot study. Open Heart. 2016 Oct 31;3(2):e000460. doi: 10.1136/openhrt-2016-000460. eCollection 2016.