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

Sponsor
Brazilian Clinical Research Institute
Study ID
NCT06396858
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
May 2, 2024
Start date
Jul 31, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
4,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Group 1
    rivaroxaban 2.5 mg Twice a day (BID) + colchicine 0.5 mg once daily (QD)
  • Active Comparator: Group 2
    rivaroxaban 2.5 mg BID + colchicine placebo QD
  • Active Comparator: Group 3
    rivaroxaban placebo BID + colchicine 0.5 mg QD
  • Placebo Comparator: Group 4
    rivaroxaban placebo BID + colchicine placebo QD

Primary Outcome Measure

Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial [ Time Frame: 12 months ]

Central Contacts

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