Antithrombotic therapies for secondary prevention in patients with cryptogenic stroke a systematic review and network meta-analysis with individual participant data

Lead Investigator: Cinzia Del Giovane, University Hospital of Modena and Reggio Emilia
Title of Proposal Research: Antithrombotic therapies for secondary prevention in patients with cryptogenic stroke a systematic review and network meta-analysis with individual participant data
Vivli Data Request: 8877
Funding Source: Supported by the Italian Ministry of Health (Grant Number: RC 2018 – J49C19000050001).
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Stroke is a life‚Äźthreatening medical condition in which brain tissue is damaged. Ischemic stroke is caused by a clot blocking the blood supply to part of the brain. There are ischemic strokes without a known origin of the clot, called cryptogenic. Because approximately 1 in 4 stroke survivors will likely have another stroke event, finding the cause of the stroke helps clinicians to select the most effective and safe pharmacological treatment to lower the likelihood of another cerebrovascular event (secondary prevention). Antithrombotic are blood thinning medicines that prevent clots from forming and growing and therefore are used to prevent the recurrence of stroke. There are two classes of antithrombotic agents, anticoagulants that slow down clotting and antiplatelets that prevent platelets from clumping. In the case of cryptogenic stroke, there is uncertainty about the best approach.
We aim to conduct a systematic review, a research project to collect, extract and interpret data from published studies on the topic, with network meta-analysis, a statistical technique that allows the quantitative comparisons of the effects interventions (medicines) that were not investigated by the same study.

Requested Studies:

Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Data Contributor: Boehringer Ingelheim
Study ID: NCT02239120
Sponsor ID: 1160.189

PRoFESS – Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
Data Contributor: Boehringer Ingelheim
Study ID: NCT00153062
Sponsor ID: 9.159

Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial
Data Contributor: Sanofi
Sponsor ID: EFC7331

CS-747S PhaseIII trial -Double-blind study of CS-747S versus clopidogrel bisulfate in elderly and/or low body weight patients with ischemic cerebrovascular accident-
Data Contributor: Daiichi Sankyo, Inc.
Study ID: CS0747S-A-J304
Sponsor ID: CS0747S-A-J304

CS-747S PhaseIII trial -Non-inferiority study of CS-747S versus clopidogrel bisulfate in patients with ischemic cerebrovascular accident.-
Data Contributor: Daiichi Sankyo, Inc.
Study ID: CS0747S-A-J303
Sponsor ID: CS0747S-A-J303