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

ConditionIschemic Stroke

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorBrazilian Clinical Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Factorial

Treatments tested in this trial

Rivaroxaban 2.5 Mg Oral Tablet
Drug
Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
Colchicine 0.5 MG
Drug
Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.
Placebo Rivaroxaban
Drug
Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
Placebo Colchicine
Drug
Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Treatment groups

4,500 Participants

are divided into 4 treatment groups

Group A: Group 1Active comparator 2 interventions

Group B: Group 2Active comparator 2 interventions

Group C: Group 3Active comparator 2 interventions

Group D: Group 4Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

12 months

Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections

Time to first hospitalization for respiratory infections

Time frame

12 months

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

Other outcomes

modified Rankin score

modified Rankin score as ordinal outcome

Time frame

12 months

Venous thromboembolism

Time to first venous thromboembolism

Time frame

12 months

New-onset atrial fibrillation

time to new-onset atrial fibrillation

Time frame

12 months

Microvascular obstruction at head MRI (substudy)

Time frame

12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brazilian Clinical Research Institute

Lead sponsor

Alliança Diagnostic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: