BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)

This study is currently recruiting participants.

Verified February 2013 by Careggi Hospital

Sponsor:

Collaborator:

ARCARD ONLUS Foundation

Information provided by (Responsible Party):

David Antoniucci, Careggi Hospital

ClinicalTrials.gov Identifier:

NCT01790854

First received: February 12, 2013

Last updated: NA

Last verified: February 2013

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 12, 2013

Last Updated Date

February 12, 2013

Start Date ^ICMJE

November 2012

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

bleeding [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consurtium criteria (11), occurring from 1 month to the end of the study.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

MACE [ Time Frame: 12 months ] [ Designated as safety issue: No ]

MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

pharmacodynamic effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
pharmacodynamic effects of shifting prasugrel maintenance dose from 10 mg to 5 mg after ACS
residual platelet reactivity (LTA) [ Time Frame: baseline - 1 month ] [ Designated as safety issue: Yes ]
correlation between residual platelet reactivity (LTA), both at baseline and at 1-month, with bleeding and ischemic events

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

BLeeding Events and Maintenance DoSe of PraSugrel

Official Title ^ICMJE

Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Adverse Reaction to Antiplatelet Agent
Acute Coronary Syndrome

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: 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

Intervention: Drug: Prasugrel dose 10 mg/day

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

450

Estimated Completion Date

October 2014

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: David Antoniucci, MD	+390557947966	david.antoniucci@virgilio.it
Contact: Nazario Carrabba, MD	+390557947966	n.carrabba@virgilio.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01790854

Other Study ID Numbers ^ICMJE

BLESS Study

Has Data Monitoring Committee

Yes

Responsible Party

David Antoniucci, Careggi Hospital

Study Sponsor ^ICMJE

David Antoniucci

Collaborators ^ICMJE

ARCARD ONLUS Foundation

Investigators ^ICMJE

Principal Investigator:

David Antoniucci, MD

Careggi Hospital, division of Invasive Cardiology

Information Provided By

Careggi Hospital

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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