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BLeeding Events and Maintenance DoSe of PraSugrel (BLESS)

Primary Purpose

Adverse Reaction to Antiplatelet Agent, Acute Coronary Syndrome

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Prasugrel dose 5 mg/day
Prasugrel dose 10 mg/day
Sponsored by
David Antoniucci
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Reaction to Antiplatelet Agent focused on measuring prasugrel, antiplatelet, Acute Coronary Syndrome

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Careggi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prasugrel dose 5 mg/day

Prasugrel dose 10 mg/day

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 12, 2013
Last Updated
July 28, 2016
Sponsor
David Antoniucci
Collaborators
A.R. CARD Onlus Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01790854
Brief Title
BLeeding Events and Maintenance DoSe of PraSugrel
Acronym
BLESS
Official Title
Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Low events rate. Scarce economical resources
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Antoniucci
Collaborators
A.R. CARD Onlus Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Reaction to Antiplatelet Agent, Acute Coronary Syndrome
Keywords
prasugrel, antiplatelet, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel dose 5 mg/day
Arm Type
Experimental
Arm Description
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
Arm Title
Prasugrel dose 10 mg/day
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Prasugrel dose 5 mg/day
Intervention Type
Drug
Intervention Name(s)
Prasugrel dose 10 mg/day
Primary Outcome Measure Information:
Title
bleeding
Description
major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consortium criteria (11), occurring from 1 month to the end of the study.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MACE
Description
MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
pharmacodynamic effects
Description
pharmacodynamic effects of shifting prasugrel maintenance dose from 10 mg to 5 mg after ACS
Time Frame
12 months
Title
residual platelet reactivity (LTA)
Description
correlation between residual platelet reactivity (LTA), both at baseline and at 1-month, with bleeding and ischemic events
Time Frame
baseline - 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Antoniucci, MD
Organizational Affiliation
Careggi Hospital, division of Invasive Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Careggi Hospital
City
Florence
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27843564
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.
Results Reference
derived

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BLeeding Events and Maintenance DoSe of PraSugrel

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