Benefit of Anticoagulation in Cryptogenic Stroke According to Biomarker Level

Lead Investigator: Joel Skaistis, Beaumont Health
Title of Proposal Research: Benefit of Anticoagulation in Cryptogenic Stroke According to Biomarker Level
Vivli Data Request: 5080
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Biomarker based risk estimates using high sensitivity troponin and N-terminal pro brain natriuretic peptide have been shown to be superior to clinical history based estimates in predicting the risk of stroke. The recently published RE-SPECT ESUS trial tested the benefit of anticoagulation in preventing recurrent stroke after an initial episode of cryptogenic stroke and detected no benefit. Patient selection for this study was not biomarker guided. It is unknown whether a subgroup identified as high risk by elevated biomarkers would benefit from anticoagulation for recurrent stroke prevention. The objective of this project is to test the interaction between biomarker levels and anticoagulation treatment benefit in a population with cryptogenic stroke.

Statistical Analysis Plan:

We will use Kaplan-Meier estimates to evaluate whether effectiveness of anticoagulation differs within subgroups of cryptogenic stroke patients defined by age groups, biomarker levels and a composite risk score. If interactions are present, we will calculate adjusted hazard ratios for the primary outcome within subgroups. Additionally, we plan to investigate the ability of ABC risk score to predict recurrent stroke with Receiver Operator Curve analysis.

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)
Sponsor: Boehringer Ingelheim
Study ID: NCT02239120
Sponsor ID: 1160.189

Public Disclosures:

J. Skaistis, J. George, H.C. Diener. Dabigatran Treatment in Embolic Stroke
of Undetermined Source and Elevated Biomarkers: the RE-SPECT ESUS Trial. CJC Open (2023). doi: 10.1016/j.cjco.2022.12.013