Why the study?
Adding very low dose rivaroxaban to dual antiplatelet therapy reduces cardiovascular events but increases bleeding, creating a need to evaluate targeted therapy based on endogenous fibrinolysis status.
Does targeted therapy with very low dose rivaroxaban or ticagrelor improve endogenous fibrinolysis in ACS patients with impaired fibrinolytic status compared to clopidogrel?
Does targeted therapy with very low dose rivaroxaban or ticagrelor improve endogenous fibrinolysis in ACS patients with impaired fibrinolytic status compared to clopidogrel?
The VaLiDate-R study is designed to evaluate whether targeted antithrombotic therapy with very low dose rivaroxaban or ticagrelor improves endogenous fibrinolysis in high-risk ACS patients.
Should not yet change practice for ACS management; leaves open whether targeting impaired endogenous.
Impaired endogenous fibrinolysis is novel biomarker that can identify patients with ACS at increased cardiovascular risk. The addition of Very Low Dose Rivaroxaban (VLDR) to dual antiplatelet therapy has been shown to reduce cardiovascular events but at a cost of increased bleeding and is therefore not suitable for all-comers. Targeted additional pharmacotherapy with VLDR to improve endogenous fibrinolysis may improve outcomes in high-risk patients, whilst avoiding unnecessary bleeding in low-risk individuals. The VaLiDate-R study (ClinicalTrials.gov Identifier: NCT03775746, EudraCT: 2018-003299-11) is an investigator-initiated, randomised, open-label, single centre trial comparing the effect of 3 antithrombotic regimens on endogenous fibrinolysis in 150 patients with ACS. Subjects whose screening blood test shows impaired fibrinolytic status (lysis time > 2000s), will be randomised to one of 3 treatment arms in a 1:1:1 ratio: clopidogrel 75 mg daily (Group 1); clopidogrel 75 mg daily plus rivaroxaban 2.5 mg twice daily (Group 2); ticagrelor 90 mg twice daily (Group 3), in addition to aspirin 75 mg daily. Rivaroxaban will be given for 30 days. Fibrinolytic status will be assessed during admission and at 2, 4 and 8 weeks. The primary outcome measure is the change in fibrinolysis time from admission to 4 weeks follow-up, using the Global Thrombosis Test. If VLDR can improve endogenous fibrinolysis in ACS, future large-scale studies would be required to assess whether targeted use of VLDR in patients with ACS and impaired fibrinolysis can translate into improved clinical outcomes, with reduction in major adverse cardiovascular events in this high-risk cohort.
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Gue et al. (2019) studied this question.
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