Coronary ArteriosclerosisPhase 2ASABYVALVNCT01466452
Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery
A Phase 2 study testing Aspirin in people with Coronary Arteriosclerosis, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
This study is a randomized open label study that implies the administration of asprin according to three different regimens. The aims of the study are: to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 2
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent of the study signed
- coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses
- age between 55 and 80
- ejection fraction > 30%.
Who cannot join
- excessive bleeding (> 1000mL / 6 h) or the need of re operation for bleeding
- perioperative myocardial infarction
- stroke or renal failure requiring dialysis and need waiting for post-operative anticoagulation
- patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention
- patients undergoing off-pump coronary artery bypass graft
- overt kidney or liver disease
- therapies that influence the coagulation
- fertile women
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino, IRCCS
Milan, Milano, 20138
Alessandro Parolari, MD PhD, +39 02 5800 ext. 2355, alessandro.parolari@ccfm.it
Alessandro Parolari, MD PhD
About this study
This study is a randomized open label study that implies the administration of asprin according to three different regimens.
The aims of the study are:
Read more
- to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.
- to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1.
The endpoints of this study are:
- To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin
- Conditions
- Coronary Arteriosclerosis
- Being tested
- Aspirin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
single-dose aspirin in 100 mg 1 tablet every 24 hours
AspirinDrug
single-dose aspirin 200 mg 1 tablet every 24 hours
AspirinDrug
double-dose aspirin 100 mg 1 tablet every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 100 | Active comparator | Not described Receives: Drug: Aspirin |
| Aspirin 200 | Active comparator | Not described Receives: Drug: Aspirin |
| Aspirin 100 x 2 | Active comparator | Not described Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin
Measured: one year
change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin
Measured: one year
Secondary outcomes (4)
change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin
Measured: one year
change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin
Measured: one year
change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin
Measured: one year
change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University, Italy, University of Chieti
- Responsible party
- Principal investigator, Alessandro Parolari, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466452
- Sponsor's protocol ID
- S181/211
- Acronym
- ASABYVALV
- Status last verified
- Nov 2011
- First submitted
- 20 Oct 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery
- ClinicalTrials.gov ID
- NCT01466452
- Acronym / sponsor ID
- ASABYVALV / S181/211
- Conditions
- Coronary Arteriosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Catholic University, Italy, University of Chieti
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 8 Nov 2011 (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.
This study is a randomized open label study that implies the administration of asprin according to three different regimens.
The aims of the study are:
- to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.
- to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1.
The endpoints of this study are:
- To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin 100 | Active comparator | Drug: Aspirin |
| Aspirin 200 | Active comparator | Drug: Aspirin |
| Aspirin 100 x 2 | Active comparator | Drug: Aspirin |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent of the study signed
- coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses
- age between 55 and 80
- ejection fraction > 30%.
Key exclusion criteria (8 listed)
- excessive bleeding (> 1000mL / 6 h) or the need of re operation for bleeding
- perioperative myocardial infarction
- stroke or renal failure requiring dialysis and need waiting for post-operative anticoagulation
- patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention
- patients undergoing off-pump coronary artery bypass graft
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 |
|---|---|---|
| Aspirinsingle-dose aspirin in 100 mg 1 tablet every 24 hours | Drug | Aspirin 100 |
| Aspirinsingle-dose aspirin 200 mg 1 tablet every 24 hours | Drug | Aspirin 200 |
| Aspirindouble-dose aspirin 100 mg 1 tablet every 12 hours | Drug | Aspirin 100 x 2 |
Primary outcome
change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin
Time frame: one year
change in the levels of 12-HETE in serum at 12 and 24 hours after administration of aspirin
Time frame: one year
4 secondary outcomes
change in the levels of 11-dehydro TXB2 urinary at 12 and 24 hours after administration of aspirin
Time frame: one year
change in the levels of 8-iso-PGF2 alpha urinary at 12 and 24 hours after administration of aspirin
Time frame: one year
change in the levels of 2-3 dinor-6-chetoPGF1 alpha at 12 and 24 hours after administration of aspirin
Time frame: one year
change in the levels of Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with Coronary Arteriosclerosis, run by Centro Cardiologico Monzino 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Nov 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Parolari, MD PhD (+39 025800 ext. 2355, alessandro.parolari@ccfm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the levels of TXB2 in serum at 12 and 24 hours after administration of aspirin (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2011.