NCT06396858Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 4500 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- Jan 2027
- Primary completion date
- Jan 2028
- Lead sponsor
- Brazilian Clinical Research Institute
- Diseases
- Stroke
- NCT number
- NCT06396858
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 4500
- From Jan 2027 to the primary completion date, Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hemorrhagic stroke or history of intracranial hemorrhage;
- Systemic treatment with a potent CYP 3A4 inhibitor (such as azole antifungals and protease inhibitors), or with a potent 3A4 inducer (such as rifampicin, phenytoin, phenobarbital, or carbamazepine);
- Prolonged treatment (\> 1 month) with immunosuppressants or systemic corticosteroids;
Other illness
- Severe renal failure, with glomerular filtration rate (by CKD-EPI) estimated at \<15 mL/min/1.73 m2;
- Severe liver failure (child C);
- Indication for full-dose anticoagulation (for example, venous thromboembolism or atrial fibrillation);
- History of inflammatory bowel disease or chronic diarrhea;
- History of recurrent pneumonia (3 or more hospitalizations in the last 12 months);
- Any other comorbidity other than stroke and CV disease (e.g., metastatic cancer) that, in the investigator's opinion, has a significant impact on the 12-month survival.
Other
- Modified Rankin score of 4 or more at randomization;
- Refusal to provide consent;
- Pregnancy or breastfeeding;
Who the study is looking for
- Patients with acute ischemic stroke aged ≥18 years old who, regardless of etiology and mechanism, do not have a definitive indication for anticoagulation, and whose symptoms onset has been within the last 14 days;
- Receiving standard therapy for acute management of ischemic stroke;
- For patients treated with fibrinolytics, a minimum period of 24 hours after the infusion of the lytic drug is required for randomization into the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.