Combination antithrombotic treatment for prevention of recurrent ischemic stroke in intracranial atherosclerotic disease (catis-icad)

Objective: We aim to establish the safety and efficacy of low-dose rivaroxaban plus ASA in preventing recurrent strokes secondary to IntraCranial Atherosclerotic Disease (ICAD). The current pilot trial is designed to obtain the factual prerequisites essential for the design of a subsequent phase III trial. Background: ICAD is highly prevalent and a major cause of stroke. Patients with a recent ICAD related stroke are at a high risk for recurrent stroke (~5.5% at 30 days, 14.9% at 1 year, and 17.2% at 2 years) despite treatment with antiplatelet agents and aggressive management of vascular risk factors. There was overwhelming efficacy of the combination antithrombotic treatment (low-dose rivaroxaban - 2.5mg bid - plus ASA) compared with ASA alone for preventing vascular outcomes in patients with systemic atherosclerosis in the recent COMPASS trial. In 27,395 patients the combination therapy showed a 49% reduction of ischemic stroke (0.51 (0.38–0.68) Design/Methods: CATIS-ICAD is an open-label, blinded endpoint, randomized, controlled, investigator-initiated pilot study that will assess the recruitment feasibility and the safety of low-dose rivaroxaban plus ASA compared with ASA for stroke prevention in patients with ischemic stroke or high-risk Transient Ischemic Attack secondary to ICAD. Sample size of 100 patients was calculated based on convenience and will be recruited over 24 months. Results: “NA” Conclusions: CATIS-ICAD will assess the effectiveness of low-dose rivaroxaban plus ASA in patients with recent ischemic stroke/high-risk TIA secondary to ICAD, an area where a huge interest exists within the stroke community. The proposed study will advance our knowledge of ICAD related stroke risk factors and prevention. Disclosure: Dr. De Sa Boasquevisque has nothing to disclose. Dr. Sharma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer AG, Daiichi Sankyo and Boehringer Ingelheim. Dr. Sharma has received research support from Bayer and Bristol-Myers Squibb. Dr. Hill has received research support from Medtronic, Boehringer Ingelheim, and NoNO Inc.Dr. Eikelboom has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Boehringer Ingelheim, Daiichi Sankyo, Bristol-Myers Squibb/Pfizer, and Janssen. Dr. Eikelboom has received research support from Bayer, Boehringer Ingelheim, Daiichi Sankyo, Bristol-Myers Squibb/Pfizer, and Janssen. Dr. Ng has nothing to disclose. Dr. Hart has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer AG. Dr. Perera has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer AG and Bristol-Myers Squibb. Dr. Perera has received research support from Bayer AG.