Ischemic StrokePhase 4ARCHIMEDESNCT06396858
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet and Colchicine 0.5 MG in people with Ischemic Stroke, run by Brazilian Clinical Research Institute.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Rivaroxaban 2.5 Mg Oral Tablet and Colchicine 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- Modified Rankin score of 4 or more at randomization;
- Refusal to provide consent;
- 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);
- Previous hemorrhagic stroke or history of intracranial hemorrhage;
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- 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);
- History of inflammatory bowel disease or chronic diarrhea;
- Prolonged treatment (> 1 month) with immunosuppressants or systemic corticosteroids;
- History of recurrent pneumonia (3 or more hospitalizations in the last 12 months);
- Pregnancy or breastfeeding;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke
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.
Read the detailed description
In patients with ischemic stroke, within 14 days of symptom onset, to establish the efficacy and safety of two strategies in parallel: low-dose rivaroxaban and low-dose colchicine, compared with placebo.
- Conditions
- Ischemic Stroke
- Being tested
- Rivaroxaban 2.5 Mg Oral Tablet, Colchicine 0.5 MG, Placebo Rivaroxaban, Placebo Colchicine
- Keywords
- Stroke, Anticoagulation, rivaroxaban, colchicine
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 Mg Oral TabletDrug
Also called Xarelto
Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
Colchicine 0.5 MGDrug
Also called Colchis
Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.
Placebo RivaroxabanDrug
Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
Placebo ColchicineDrug
Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | rivaroxaban 2.5 mg Twice a day (BID) + colchicine 0.5 mg once daily (QD) Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet; Drug: Colchicine 0.5 MG |
| Group 2 | Active comparator | rivaroxaban 2.5 mg BID + colchicine placebo QD Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet; Drug: Placebo Colchicine |
| Group 3 | Active comparator | rivaroxaban placebo BID + colchicine 0.5 mg QD Receives: Drug: Colchicine 0.5 MG; Drug: Placebo Rivaroxaban |
| Group 4 | Placebo comparator | rivaroxaban placebo BID + colchicine placebo QD Receives: Drug: Placebo Rivaroxaban; Drug: Placebo Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial
Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial revascularization
Measured: 12 months
Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification
Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification
Measured: 12 months
Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections
Time to first hospitalization for respiratory infections
Measured: 12 months
Secondary outcomes (6)
Time to fatal or non-fatal stroke
Time to fatal or non-fatal stroke
Measured: 12 months
Time to CV death, MI, or stroke
Time to CV death, MI, or stroke
Measured: 12 months
Time to death from all causes, MI, or stroke
Time to death from all causes, MI, or stroke
Measured: 12 months
Time to fatal or non-fatal stroke, death, or transient ischemic attack
Time to fatal or non-fatal stroke, death, or transient ischemic attack
Measured: 12 months
Net clinical endpoint: time to CV death, MI, stroke, fatal bleeding, or critical site bleeding
Time to CV death, MI, stroke, fatal bleeding, or critical site bleeding
Measured: 12 months
Time to all-cause death
Time to all-cause death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Factorial
- Model description
- they will be randomized, simultaneously, in a 1:1 ratio, to rivaroxaban 2.5 mg BID or placebo, and colchicine 0.5 mg QD versus placebo, in a 2x2 factorial design. Therefore, the study will have four possible groups: rivaroxaban 2.5 mg BID + colchicine 0.5 mg QD; rivaroxaban 2.5 mg BID + colchicine placebo QD; rivaroxaban placebo BID + colchicine 0.5 mg QD; or rivaroxaban placebo BID + colchicine placebo QD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brazilian Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alliança Diagnostic
- Responsible party
- Sponsor
- Investigators
- Renato D Lopes, MD, PhD, Study chair, Brazilian Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396858
- Sponsor's protocol ID
- 001/2023
- Acronym
- ARCHIMEDES
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06396858
- Acronym / sponsor ID
- ARCHIMEDES / 001/2023
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Anticoagulation, rivaroxaban, colchicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Brazilian Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Alliança Diagnostic
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 2 May 2024 (actual)
- 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.
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.
Detailed description
In patients with ischemic stroke, within 14 days of symptom onset, to establish the efficacy and safety of two strategies in parallel: low-dose rivaroxaban and low-dose colchicine, compared with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- they will be randomized, simultaneously, in a 1:1 ratio, to rivaroxaban 2.5 mg BID or placebo, and colchicine 0.5 mg QD versus placebo, in a 2x2 factorial design. Therefore, the study will have four possible groups: rivaroxaban 2.5 mg BID + colchicine 0.5 mg QD; rivaroxaban 2.5 mg BID + colchicine placebo QD; rivaroxaban placebo BID + colchicine 0.5 mg QD; or rivaroxaban placebo BID + colchicine placebo QD
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Rivaroxaban 2.5 Mg Oral Tablet, Drug: Colchicine 0.5 MGrivaroxaban 2.5 mg Twice a day (BID) + colchicine 0.5 mg once daily (QD) |
| Group 2 | Active comparator | Drug: Rivaroxaban 2.5 Mg Oral Tablet, Drug: Placebo Colchicinerivaroxaban 2.5 mg BID + colchicine placebo QD |
| Group 3 | Active comparator | Drug: Colchicine 0.5 MG, Drug: Placebo Rivaroxabanrivaroxaban placebo BID + colchicine 0.5 mg QD |
| Group 4 | Placebo comparator | Drug: Placebo Rivaroxaban, Drug: Placebo Colchicinerivaroxaban placebo BID + colchicine placebo QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Modified Rankin score of 4 or more at randomization;
- Refusal to provide consent;
- 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);
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 |
|---|---|---|
| Rivaroxaban 2.5 Mg Oral TabletAlso: XareltoPatients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months. | Drug | Group 1, Group 2 |
| Colchicine 0.5 MGAlso: ColchisPatients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months. | Drug | Group 1, Group 3 |
| Placebo RivaroxabanPatients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months. | Drug | Group 3, Group 4 |
| Placebo ColchicinePatients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months. | Drug | Group 2, Group 4 |
Primary outcome
Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial
Time frame: 12 months
Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial revascularization
Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification
Time frame: 12 months
Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification
Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections
Time frame: 12 months
Time to first hospitalization for respiratory infections
6 secondary outcomes
Time to fatal or non-fatal stroke
Time frame: 12 months
Time to CV death, MI, or stroke
Time frame: 12 months
Time to death from all causes, MI, or stroke
Time frame: 12 months
Time to fatal or non-fatal stroke, death, or transient ischemic attack
Time frame: 12 months
Net clinical endpoint: time to CV death, MI, stroke, fatal bleeding, or critical site bleeding
Time frame: 12 months
Time to all-cause death
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
Renato D Lopes, MD, PhD study chair
Brazilian Clinical Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 2.5 Mg Oral Tablet and Colchicine 0.5 MG in people with Ischemic Stroke, run by Brazilian Clinical Research Institute.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Remo Furtado, MD, PhD (55 11 59047339, remo.furtado@bcri.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial (time frame: 12 months). The study lists 3 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 30 Oct 2026.