NCT01790854

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

February 12, 2013

Last Update Submit

July 28, 2016

Conditions

Adverse Reaction to Antiplatelet AgentAcute Coronary Syndrome

Keywords

prasugrelantiplateletAcute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • MACE

    12 months

Other Outcomes (2)

  • pharmacodynamic effects

    12 months

  • residual platelet reactivity (LTA)

    baseline - 1 month

Study Arms (2)

Prasugrel dose 5 mg/day

EXPERIMENTAL

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

Prasugrel dose 10 mg/day

ACTIVE COMPARATOR

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

Interventions

Prasugrel dose 5 mg/dayDRUG
Prasugrel dose 5 mg/day
Prasugrel dose 10 mg/dayDRUG
Prasugrel dose 10 mg/day

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all ACS patients treated with PCI (percutaneous coronary intervention) and dual antiplatelet therapy (DAPT: aspirin plus prasugrel).
  • Informed written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Careggi Hospital

Florence, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27843564DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • David Antoniucci, MD

    Careggi Hospital, division of Invasive Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Division of Invasive Cardiology

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 13, 2013

Study Start

November 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

IT(1)