A Phase 4 interventional study of Oral tranexamic acid and Exacyl® in Coronary Artery Disease and Perioperative Bleeding, sponsored by Clinique Saint-Luc. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Clinique Saint-Luc · Phase 4, Interventional, and Prevention
Among 189 studies in Coronary Artery Disease with a site in Belgium — 26 open to participants now, 41 under way, 7 of them phase 3. Coronary Artery Disease · Belgium.
Among the 189 studies in Coronary Artery Disease with a site in Belgium, this one is the 94th largest by planned enrollment of the 148 interventional ones that give a count, is one of 7 that started in 2026, is one of 21 in phase 4, reaches primary completion later than 30 of the 40 other live ones, and was the 188th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
Browse Coronary Artery Disease studies →26 of the 189 studies in Coronary Artery Disease with a site in Belgium are open now. Recruiting first, the newest first:
EBI Anti Sepsis BV · Sites in Belgium, United States, Netherlands and 1 more country
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Catharina Ziekenhuis Eindhoven · Sites in Belgium, Netherlands
Fundación EPIC · Sites in Belgium, United States, Spain and 1 more country
VZW Cardiovascular Research Center Aalst · Sites in Belgium
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
189 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 19 · Phase 3 33 · Phase 4 21
First in 2002; this study’s year is marked. 7 started in 2026.
This study's planned enrollment of 160 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Median enrollment 282 across the 148 interventional studies, 332 across the 41 observational. Of the 127 that completed or were terminated, 45 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
115 of 189 have an industry lead sponsor. The 10 most frequent:
Clinique Saint-Luc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Clinique Saint-Luc has 1 study filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
9 of the studies in Coronary Artery Disease with a site in Belgium that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05952206Phase 3iVascular S.L.U.Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy | 2027-01-13 |
| NCT07357675Phase 3EBI Anti Sepsis BVA Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery. | 2027-10-01 |
| NCT06095765Phase 3AZ Sint-Jan AVColchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention | 2027-11-01 |
| NCT04545112XeltisXeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH) | 2027-02 |
| NCT07036770Universitaire Ziekenhuizen KU LeuvenCoronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques | 2027-05-31 |
Among the 189 studies in Coronary Artery Disease with a site in Belgium, from their registry updates:
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Tranexamic acid is commonly administered intravenously during cardiac surgery to reduce perioperative bleeding. Oral tranexamic acid may offer a simpler and less costly alternative, but its effectiveness in patients undergoing off-pump coronary artery bypass grafting has not been adequately established.
TRANSCAB is a randomized, double-blind, parallel-group, non-inferiority clinical trial comparing oral and intravenous tranexamic acid in adults undergoing elective off-pump coronary artery bypass grafting. Participants will receive either oral tranexamic acid before surgery with an intravenous placebo at induction, or oral placebo before surgery with intravenous tranexamic acid at induction.
The primary objective is to determine whether oral tranexamic acid is non-inferior to intravenous tranexamic acid for reducing postoperative blood loss. Secondary objectives include comparing transfusion requirements, postoperative hemoglobin levels, reoperation for bleeding, thromboembolic complications, seizures, acute kidney injury, and other postoperative outcomes.
Perioperative bleeding remains an important complication of coronary artery bypass surgery and may lead to blood transfusion, reoperation, prolonged hospitalization, and increased postoperative morbidity. Tranexamic acid is an antifibrinolytic drug widely used in cardiac surgery to reduce bleeding and transfusion requirements. It is most commonly administered intravenously, although oral administration may provide adequate systemic exposure while simplifying drug preparation and administration.
TRANSCAB is a monocentric, prospective, randomized, double-blind, placebo-controlled, parallel-group, non-inferiority trial conducted in adult patients undergoing elective off-pump coronary artery bypass grafting.
A total of 160 participants will be randomized in a 1:1 ratio to one of two treatment groups:
Participants, clinicians involved in perioperative management, outcome assessors, and investigators will remain blinded to treatment allocation. Study treatments will be prepared and dispensed according to the randomization list by the hospital pharmacy.
The primary objective is to assess whether oral tranexamic acid is non-inferior to intravenous tranexamic acid in reducing postoperative blood loss following off-pump coronary artery bypass grafting.
Secondary and safety outcomes will assess perioperative transfusion requirements, postoperative hemoglobin changes, clinically significant bleeding, reoperation for bleeding, thromboembolic events, seizures, acute kidney injury, mortality, duration of intensive care and hospital stay, and other postoperative complications specified in the protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
or precaution to tranexamic acid according to the applicable product information, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 2 g of oral tranexamic acid as four 500 mg tablets approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
Drug: Oral tranexamic acid · Drug: Intravenous placebo
Participants receive four matching oral placebo tablets approximately 2 hours before surgical incision, together with 1 g of intravenous tranexamic acid administered at induction or incision according to the study protocol.
Drug: Exacyl®
Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.
Tranexamic acid, 1 g intravenously, diluted in 0.9% sodium chloride to a total volume of 50 mL and administered at induction or incision according to the study protocol.
Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
Total cumulative volume of blood collected from mediastinal and pleural chest drains during the first 24 hours after completion of surgery, expressed in milliliters.
Time frame: From completion of surgery to 24 hours postoperatively
Number of Participants Receiving Red Blood Cell Transfusion
Number and proportion of participants receiving at least one unit of packed red blood cells during surgery or the postoperative hospital stay, and the total number of units transfused per participant.
Time frame: From surgery until hospital discharge, up to 30 days
Hemoglobin Concentration at 24 Hours After Surgery (g/dL)
Hemoglobin concentration measured from routine postoperative blood samples, expressed in grams per deciliter.
Time frame: At 24 hours after surgery
Number of Participants Requiring Reoperation for Bleeding
Number and proportion of participants requiring surgical re-exploration because of postoperative bleeding or cardiac tamponade.
Time frame: During the index hospitalization, up to 30 days
Number of Participants With Thromboembolic Events
Occurrence of clinically diagnosed arterial or venous thromboembolic events, including myocardial infarction, ischemic stroke, deep vein thrombosis, or pulmonary embolism.
Time frame: From study intervention until 30 days after surgery
Number of Participants With Postoperative Seizures
Occurrence of clinically diagnosed postoperative seizures.
Time frame: During the index hospitalization, up to 30 days
Number of Participants With Acute Kidney Injury According to Kidney Disease: Improving Global Outcomes (KDIGO) Criteria
Number of participants with postoperative acute kidney injury classified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria (Stages 1, 2, or 3).
Time frame: Within 7 days after surgery or until hospital discharge, whichever occurs first
Number of Participants With All-Cause Mortality Within 30 Days After Surgery
Death from any cause.
Time frame: Within 30 days after surgery
Length of Intensive Care Unit Stay (days)
Duration of the postoperative intensive care unit stay, expressed in hours or days.
Time frame: From intensive care unit admission until discharge from the intensive care unit, up to 30 days
Length of Hospital Stay (days)
Duration of the postoperative hospital stay, expressed in days.
Time frame: From the date of surgery until hospital discharge, up to 30 days
Plan to share: Yes — De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the Sponsor and Coordinating Investigator and will require an approved research proposal and a signed data use or data transfer agreement. Data sharing will be subject to applicable ethical, legal, regulatory, and data-protection requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Beginning 12 months after publication of the primary results and available for 5 years.
Access criteria: Access may be granted to qualified researchers whose proposed use of the data has been approved by the Sponsor. Requests must include a scientifically sound research proposal and will require a signed data use or data transfer agreement. Data will be shared only in accordance with applicable data-protection, ethical, and regulatory requirements.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.
Of 180 non-industry phase 4 interventional studies under Coronary Artery Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 20 months is below that.
Counting every sponsor, half of 193 studies reached it within 35 months; a quarter within 19 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Clinique Saint-Luc