Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Matching placebos will be produced for rivaroxaban and colchicine.

Study Groups

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Group 1

rivaroxaban 2.5 mg Twice a day (BID) + colchicine 0.5 mg once daily (QD)

Group Type ACTIVE_COMPARATOR

Rivaroxaban 2.5 Mg Oral Tablet

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.

Colchicine 0.5 MG

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Group 2

rivaroxaban 2.5 mg BID + colchicine placebo QD

Group Type ACTIVE_COMPARATOR

Rivaroxaban 2.5 Mg Oral Tablet

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.

Placebo Colchicine

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Group 3

rivaroxaban placebo BID + colchicine 0.5 mg QD

Group Type ACTIVE_COMPARATOR

Colchicine 0.5 MG

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Placebo Rivaroxaban

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.

Group 4

rivaroxaban placebo BID + colchicine placebo QD

Group Type PLACEBO_COMPARATOR

Placebo Rivaroxaban

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.

Placebo Colchicine

Intervention Type DRUG

Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Interventions

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Rivaroxaban 2.5 Mg Oral Tablet

Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.

Intervention Type DRUG

Colchicine 0.5 MG

Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Intervention Type DRUG

Placebo Rivaroxaban

Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.

Intervention Type DRUG

Placebo Colchicine

Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Intervention Type DRUG

Other Intervention Names

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Xarelto Colchis

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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;
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No