Coronary Heart DiseasePhase 3NCT02942680
Efficacy and Safety of Aspirin Therapy With CABG
A Phase 3 study testing acetylsalicylic acid started for 24 hours before surgery and acetylsalicylic acid stayed for 5 days before surgery in people with Coronary Heart Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- acetylsalicylic acid started for 24 hours before surgery and acetylsalicylic acid stayed for 5 days before surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2016to Jan 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Patient able to give informed consent
Who cannot join
- Missing consent
- Urgent or emergent surgery
- Off-pump CABG
- Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
- History of bleeding diathesis, significant GI bleed, ICH, or liver failure
- Allergy to or intolerance of aspirin
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Meshalkin State Research Institute of Circulation Pathology
Novosibirsk, 630055
Aleksey kurguzov, +79137011917, aleksey_kurguzov@mail.ru
About this study
Official title: A Prospective Randomized Study of the Efficacy and Safety of Aspirin Therapy With CABG
evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation
Read the detailed description
The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe.
The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations
- Conditions
- Coronary Heart Disease
- Being tested
- acetylsalicylic acid started for 24 hours before surgery, acetylsalicylic acid stayed for 5 days before surgery
- Keywords
- coronary artery bypass grafting
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acid started for 24 hours before surgeryDrug
acetylsalicylic acid stayed for 5 days before surgeryDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | acetylsalicylic acid started for 24 hours before surgery and determination of platelet function Receives: Drug: acetylsalicylic acid started for 24 hours before surgery |
| Control | Other | acetylsalicylic acid stayed for 5 days before surgery and determination of platelet function Receives: Drug: acetylsalicylic acid stayed for 5 days before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
on discharge drains after surgery in milliliters
Measured: 24 hours after surgery
Secondary outcomes (3)
myocardial infarction
Measured: myocardial infarction by 30th day after procedure
ischemic stroke
Measured: stroke by 30th day after procedure
repeat revascularization
Measured: repeat revascularization within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alexander M. Chernyavskiy, MD PhD, Study chair, Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942680
- Sponsor's protocol ID
- 1184
- Status last verified
- Jun 2016
- First submitted
- 31 Jan 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of the Efficacy and Safety of Aspirin Therapy With CABG
- ClinicalTrials.gov ID
- NCT02942680
- Acronym / sponsor ID
- 1184
- Conditions
- Coronary Heart Disease
- Keywords
- coronary artery bypass grafting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 24 Oct 2016 (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.
evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation
Detailed description
The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe.
The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: acetylsalicylic acid started for 24 hours before surgeryacetylsalicylic acid started for 24 hours before surgery and determination of platelet function |
| Control | Other | Drug: acetylsalicylic acid stayed for 5 days before surgeryacetylsalicylic acid stayed for 5 days before surgery and determination of platelet function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Patient able to give informed consent
Key exclusion criteria (6 listed)
- Missing consent
- Urgent or emergent surgery
- Off-pump CABG
- Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
- History of bleeding diathesis, significant GI bleed, ICH, or liver failure
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 |
|---|---|---|
| acetylsalicylic acid started for 24 hours before surgery | Drug | Experimental |
| acetylsalicylic acid stayed for 5 days before surgery | Drug | Control |
Primary outcome
on discharge drains after surgery in milliliters
Time frame: 24 hours after surgery
3 secondary outcomes
myocardial infarction
Time frame: myocardial infarction by 30th day after procedure
ischemic stroke
Time frame: stroke by 30th day after procedure
repeat revascularization
Time frame: repeat revascularization within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Alexander M. Chernyavskiy, MD PhD study chair
Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acetylsalicylic acid started for 24 hours before surgery and acetylsalicylic acid stayed for 5 days before surgery in people with Coronary Heart Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 6 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 24 Oct 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 Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Aleksey Kurguzov (+9137011917, Aleksey_kurguzov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
on discharge drains after surgery in milliliters (time frame: 24 hours after surgery). 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 24 Oct 2016.