BridgeMD
RIISC
EU CTIS ID: 2024-513669-38-00
What this study is testing
To evaluate the long-term efficacy of low dose colchicine on the reduction of a composite primary outcome cluster of recurrent major vascular events
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cerebral infarction (CI) proven by neuro-imaging (MRI or head-CT), immediately once the neurologic deficit is stabilized (investigator judgement) if the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event (TIA with documented ischemic lesion (MRI or CT) in the appropriate area corresponding to the symptoms will be considered CI, following the current definition)
- medical examination before the participation to the research
- Under contraception in case of childbearing potential (highly effective: 1) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation et 2) progestogen-only)
- Pregnancy test for women of childbearing potential
- AND documented atherosclerotic stenosis:- presence of carotid atherosclerotic stenosis (on the basis of carotid duplex, CTA, MRA, XRA – only the report will be required to document atherosclerotic disease) ipsilateral to the cerebral ischemic symptoms -OR presence of atherosclerotic stenosis of another cerebral artery (documented vertebral artery stenosis, basilar artery stenosis, other intracranial artery stenosis) ipsilateral to the ischemic area -OR presence of atherosclerotic disease of the aortic arch with a plaque ≥4mm in thickness with or without superimposed thrombus, OR a plaque <4 mm with a superimposed mobile thrombus (detected by transesophageal echocardiography or CT angiography)
- OR with a history of symptomatic coronary artery disease
You likely can't join if
- Hypersensitivity to colchicine or any of the excipients.
- Patients participating in another pharmaco therapeutic program with an experimental therapy that is known to affect colchicine therapy.
- Leukopenia <3000UI/μl
- Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease)
- Patients with severe renal impairment (creatinine clearance < 30 ml/min)
- Patients with severe hepatic impairment (Prothrombin Time < 50%),
See the full eligibility criteria
Who can join
- Cerebral infarction (CI) proven by neuro-imaging (MRI or head-CT), immediately once the neurologic deficit is stabilized (investigator judgement) if the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event (TIA with documented ischemic lesion (MRI or CT) in the appropriate area corresponding to the symptoms will be considered CI, following the current definition)
- medical examination before the participation to the research
- Under contraception in case of childbearing potential (highly effective: 1) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation et 2) progestogen-only)
- Pregnancy test for women of childbearing potential
- AND documented atherosclerotic stenosis:- presence of carotid atherosclerotic stenosis (on the basis of carotid duplex, CTA, MRA, XRA – only the report will be required to document atherosclerotic disease) ipsilateral to the cerebral ischemic symptoms -OR presence of atherosclerotic stenosis of another cerebral artery (documented vertebral artery stenosis, basilar artery stenosis, other intracranial artery stenosis) ipsilateral to the ischemic area -OR presence of atherosclerotic disease of the aortic arch with a plaque ≥4mm in thickness with or without superimposed thrombus, OR a plaque <4 mm with a superimposed mobile thrombus (detected by transesophageal echocardiography or CT angiography)
- OR with a history of symptomatic coronary artery disease
- OR TIA lasting more 10 minutes or more (with motor symptoms or aphasia/dysarthria or visual defect), with total resolution and no brain lesion on neuro-imaging (TIA) If the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event - AND with ipsilateral carotid stenosis that was revascularized (endarterectomy or stenting) -OR with ipsilateral, potentially causal intracranial stenosis ≥70%
- with no clear indication of colchicine treatment (gout, Mediterranean fever)
- age equal or above 18
- Rankin score less than ≤4 (ranges from 0 to 6, with 0 indicating no symptoms, 1 no disability, 2 to 3 needing some help with daily activities, 4 to 5 dependent or bedridden, and 6 death)
- fully informed and signed inform consent
- with social security number
What rules you out
- Hypersensitivity to colchicine or any of the excipients.
- Patients participating in another pharmaco therapeutic program with an experimental therapy that is known to affect colchicine therapy.
- Leukopenia <3000UI/μl
- Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease)
- Patients with severe renal impairment (creatinine clearance < 30 ml/min)
- Patients with severe hepatic impairment (Prothrombin Time < 50%),
- Immunosuppression (all immunosuppressive treatments are forbidden, except for inhaled form corticosteroids),, medullary aplasia
- Active chronic inflammatory disease with chronically elevated blood CRP/hsCRP levels (as in lupus or Horton's disease; patients with asthma or COPD are eligible),
- Chronic active infection (e.g. tuberculosis). HIV is accepted if treatments taken do not interact with experimental treatments,
- Evolving cancer with a life expectancy less than 3 years,
- Hemodynamic instability (need for amines for more than 24 hours, circulatory assistance)
- Anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors than cannot be stopped for the course of the course of this study
- A recent severe sepsis (7 days) or all recent acute reaches
- Chronic treatment (for more than 6 months) with corticosteroids (oral or intravenous) or NSAIDs (or repeated high-dose intake for less than 7 days).
- Prohibited treatments: All treatments contraindicated during the use of colchicine for a few clinical cases, such as chronic inflammatory diseases and chronic infectious diseases, we will ask the coordinating investigator to validate the patient's eligibility.
- CI/TIA due to arterial dissection (as documented following the judgment of the investigator) or due to cardiac source of embolism without documented atherosclerotic disease (e.g., mitral stenosis or endomyocardial fibrosis, endocarditis) a patient with atrial fibrillation, or with a history of myocardial infarction, or with calcified aortic stenosis will be eligible if the above inclusion criteria are also met]
- Symptomatic hemorrhagic stroke (the mere presence of asymptomatic cerebral hemosiderin deposits –so called “microbleedings”
- Uncontrolled hypertension (investigator judgement)
- Follow-up visit impossible or anticipated bad compliance.
- Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits
- Anticipated pregnancy at time of enrollment in the study
- Breastfeeding woman
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.