Adverse Reaction to Antiplatelet AgentPhase 4BLESSNCT01790854
BLeeding Events and Maintenance DoSe of PraSugrel
A Phase 4 study testing Prasugrel dose 5 mg/day and Prasugrel dose 10 mg/day in people with Adverse Reaction to Antiplatelet Agent and Acute Coronary Syndrome, run by David Antoniucci at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Adverse Reaction to Antiplatelet Agent, Acute Coronary Syndrome
- What is being tested?
- Prasugrel dose 5 mg/day and Prasugrel dose 10 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all ACS patients treated with PCI (percutaneous coronary intervention) and dual antiplatelet therapy (DAPT: aspirin plus prasugrel).
- Informed written consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Being tested
- Prasugrel dose 5 mg/day, Prasugrel dose 10 mg/day
- Keywords
- prasugrel, antiplatelet, Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasugrel dose 5 mg/dayDrug
Prasugrel dose 10 mg/dayDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Prasugrel dose 10 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
MACE
MACE (cardiac death, Myocardial Infarction, stroke) occurring from 1 month to the end of the study; late stent thrombosis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Low events rate. Scarce economical resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Reaction to Antiplatelet AgentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Antoniucci
- Sponsor type
- University, hospital or other
- Collaborators
- A.R. CARD Onlus Foundation
- Responsible party
- Sponsor-investigator, David Antoniucci, Careggi Hospital
- Investigators
- David Antoniucci, MD, Principal investigator, Careggi Hospital, division of Invasive Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790854
- Sponsor's protocol ID
- BLESS Study
- Acronym
- BLESS
- Status last verified
- Jul 2016
- First submitted
- 12 Feb 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 27843564
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bless Study (BLeeding Events and Maintenance DoSe of PraSugrel)
- ClinicalTrials.gov ID
- NCT01790854
- Acronym / sponsor ID
- BLESS / BLESS Study
- Keywords
- prasugrel, antiplatelet, Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low events rate. Scarce economical resources
- Enrolment
- 195 participants (actual)
- Lead sponsor
- David AntoniucciUniversity, hospital or other
- Collaborators
- A.R. CARD Onlus Foundation
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel dose 5 mg/day | Experimental | Drug: Prasugrel dose 5 mg/day225 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 |
| Prasugrel dose 10 mg/day | Active comparator | Drug: Prasugrel dose 10 mg/day225 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 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all ACS patients treated with PCI (percutaneous coronary intervention) and dual antiplatelet therapy (DAPT: aspirin plus prasugrel).
- Informed written consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prasugrel dose 5 mg/day | Drug | Prasugrel dose 5 mg/day |
| Prasugrel dose 10 mg/day | Drug | Prasugrel dose 10 mg/day |
Primary outcome
bleeding
Time frame: 12 months
major, minor and minimal bleeding defined according BARC (Bleeding Academic Research Consortium criteria (11), occurring from 1 month to the end of the study.
1 secondary outcome
MACE
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Low events rate. Scarce economical resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Derived from this study: PubMed 27843564Carrabba 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Antoniucci, MD principal investigator
Careggi Hospital, division of Invasive Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel dose 5 mg/day and Prasugrel dose 10 mg/day in people with Adverse Reaction to Antiplatelet Agent and Acute Coronary Syndrome, run by David Antoniucci at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low events rate. Scarce economical resources). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01790854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.