Coronary Artery DiseasePhase 4NCT03049085
Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
A Phase 4 study testing Aspirin and vitamin C in people with Coronary Artery Disease and Aspirin, run by Medinet Heart Centre at 1 site in Poland.
Trial summary
Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Aspirin
- What is being tested?
- Aspirin and vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2017to May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB)
- Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB
Who cannot join
- Patients undergoing on-pump coronary artery bypass grafting
- Patients in whom antiplatelet therapy was not stopped 5-7 days prior to OPCAB
- Intraoperative conversion to on-pump coronary artery bypass grafting
- Patients with inherited blood-clotting disorders
- Patients undergoing other cardiac operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial
Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.
- Conditions
- Coronary Artery Disease, Aspirin
- Keywords
- OPCAB, ASA, 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
Also called Acetylsalicylic acid
preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB
vitamin CDrug
preoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB
| Study group | Role | What they receive |
|---|---|---|
| Aspirin group | Active comparator | a 75 mg uncoated aspirin is administered 2 hours prior to OPCAB Receives: Drug: Aspirin |
| Placebo group | Placebo comparator | 75 mg Vit. C is administered 2 hours prior OPCAB Receives: Drug: vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Measured: 6 hours following OPCAB
Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Measured: 12 hours following OPCAB
Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Measured: 24 hours following OPCAB
Myocardial Injury
Myocardial injury detected by Troponin T (ng/ml)
Measured: 72 hours following OPCAB
Inflammation
Inflammation detected by CRP (mg/l)
Measured: 6 hours following OPCAB
Inflammation
Inflammation detected by CRP (mg/l)
Measured: 12 hours following OPCAB
Inflammation
Inflammation detected by CRP (mg/l)
Measured: 24 hours following OPCAB
Inflammation
Inflammation detected by CRP (mg/l)
Measured: 72 hours following OPCAB
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
Measured: 6 hours following OPCAB
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
Measured: 12 hours following OPCAB
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
Measured: 24 hours following OPCAB
Kidney Injury
Kidney injury detected by creatinine (mg/dl)
Measured: 72 hours following OPCAB
All-cause mortality or MACE up to 30 days after surgery
Measured: 30 days after surgery
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)
Measured: 6 hours following OPCAB
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)
Measured: 12 hours following OPCAB
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)
Measured: 24 hours following OPCAB
Myocardial Injury
Myocardial injury detected by CK-MB (U/l)
Measured: 72 hours following OPCAB
Secondary outcomes (3)
Postoperative drainage (ml)
Measured: 12 hours and 24 hours following OPCAB
Bleeding complication
reoperation for bleeding, cardiac tamponade
Measured: < 30 days following OPCAB
Blood transfusions (units)
Measured: < 30 days following OPCAB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medinet Heart Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049085
- Sponsor's protocol ID
- Preoperative aspirin-OPCAB
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting: A Double-blind, Placebo-controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT03049085
- Acronym / sponsor ID
- Preoperative aspirin-OPCAB
- Conditions
- Coronary Artery Disease, Aspirin
- Keywords
- OPCAB, ASA, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medinet Heart CentreUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 9 Feb 2017 (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.
Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin group | Active comparator | Drug: Aspirina 75 mg uncoated aspirin is administered 2 hours prior to OPCAB |
| Placebo group | Placebo comparator | Drug: vitamin C75 mg Vit. C is administered 2 hours prior OPCAB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible patients undergoing off-pump coronary artery bypass grafting (OPCAB)
- Patients in whom antiplatelet therapy was stopped 5-7 days prior to OPCAB
Key exclusion criteria (5 listed)
- Patients undergoing on-pump coronary artery bypass grafting
- Patients in whom antiplatelet therapy was not stopped 5-7 days prior to OPCAB
- Intraoperative conversion to on-pump coronary artery bypass grafting
- Patients with inherited blood-clotting disorders
- Patients undergoing other cardiac operations
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic acidpreoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB | Drug | Aspirin group |
| vitamin Cpreoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB | Drug | Placebo group |
Primary outcome
Myocardial Injury
Time frame: 6 hours following OPCAB
Myocardial injury detected by Troponin T (ng/ml)
Myocardial Injury
Time frame: 12 hours following OPCAB
Myocardial injury detected by Troponin T (ng/ml)
Myocardial Injury
Time frame: 24 hours following OPCAB
Myocardial injury detected by Troponin T (ng/ml)
Myocardial Injury
Time frame: 72 hours following OPCAB
Myocardial injury detected by Troponin T (ng/ml)
Inflammation
Time frame: 6 hours following OPCAB
Inflammation detected by CRP (mg/l)
Inflammation
Time frame: 12 hours following OPCAB
Inflammation detected by CRP (mg/l)
Inflammation
Time frame: 24 hours following OPCAB
Inflammation detected by CRP (mg/l)
Inflammation
Time frame: 72 hours following OPCAB
Inflammation detected by CRP (mg/l)
Kidney Injury
Time frame: 6 hours following OPCAB
Kidney injury detected by creatinine (mg/dl)
Kidney Injury
Time frame: 12 hours following OPCAB
Kidney injury detected by creatinine (mg/dl)
Kidney Injury
Time frame: 24 hours following OPCAB
Kidney injury detected by creatinine (mg/dl)
Kidney Injury
Time frame: 72 hours following OPCAB
Kidney injury detected by creatinine (mg/dl)
All-cause mortality or MACE up to 30 days after surgery
Time frame: 30 days after surgery
Myocardial Injury
Time frame: 6 hours following OPCAB
Myocardial injury detected by CK-MB (U/l)
Myocardial Injury
Time frame: 12 hours following OPCAB
Myocardial injury detected by CK-MB (U/l)
Myocardial Injury
Time frame: 24 hours following OPCAB
Myocardial injury detected by CK-MB (U/l)
Myocardial Injury
Time frame: 72 hours following OPCAB
Myocardial injury detected by CK-MB (U/l)
3 secondary outcomes
Postoperative drainage (ml)
Time frame: 12 hours and 24 hours following OPCAB
Bleeding complication
Time frame: < 30 days following OPCAB
Blood transfusions (units)
Time frame: < 30 days following OPCAB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aspirin and vitamin C in people with Coronary Artery Disease and Aspirin, run by Medinet Heart Centre at 1 site in Poland.
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 5 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 9 Feb 2017. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
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?
Myocardial Injury (time frame: 6 hours following OPCAB). The study lists 17 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 9 Feb 2017.