BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)

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).

Study Overview

• Status: Terminated
• Conditions: Acute Coronary Syndrome; Adverse Reaction to Antiplatelet Agent
• Intervention / Treatment: Drug: Prasugrel dose 5 mg/day; Drug: Prasugrel dose 10 mg/day

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy
    • Careggi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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	Drug: Prasugrel dose 10 mg/day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: David Antoniucci
• Collaborators: A.R. CARD Onlus Foundation
• Investigators: Principal Investigator: David Antoniucci, MD, Careggi Hospital, Division of Invasive Cardiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: prasugrel; Acute Coronary Syndrome; antiplatelet
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride
• Other Study ID Numbers: BLESS Study