BLeeding Events and Maintenance DoSe of PraSugrel

Acute Coronary Syndrome Clinical Trial

— BLESS  

Official title:

Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01790854
• Other study ID #: BLESS Study
• Status: Terminated
• Phase: Phase 4
• First received: February 12, 2013
• Last updated: July 28, 2016
• Start date: November 2012
• Est. completion date: October 2014

Study information

• Verified date: July 2016
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 195
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Adverse Reaction to Antiplatelet Agent

Intervention

Drug:
• Prasugrel dose 5 mg/day

• Prasugrel dose 10 mg/day

Locations

Country	Name	City	State
Italy	Careggi Hospital	Florence

Sponsors (2)

Lead Sponsor	Collaborator
David Antoniucci	A.R. CARD Onlus Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pharmacodynamic effects	pharmacodynamic effects of shifting prasugrel maintenance dose from 10 mg to 5 mg after ACS	12 months	Yes
Other	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	Yes
Primary	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	Yes
Secondary	MACE	MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.	12 months	No