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

Официальное название

A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат Colchicine 0.5 MG
  Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.
• Препарат Placebo Rivaroxaban
  Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
• Препарат Placebo Colchicine
  Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Первичные конечные точки

• Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial [Срок оценки: 12 months]
• Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification [Срок оценки: 12 months]
• Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Time to fatal or non-fatal stroke [Срок оценки: 12 months]
• Time to CV death, MI, or stroke [Срок оценки: 12 months]
• Time to death from all causes, MI, or stroke [Срок оценки: 12 months]
• Time to fatal or non-fatal stroke, death, or transient ischemic attack [Срок оценки: 12 months]
• Net clinical endpoint: time to CV death, MI, stroke, fatal bleeding, or critical site bleeding [Срок оценки: 12 months]
• Time to all-cause death [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06396858 · 001/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗