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Rationale and design of "Can Very Low Dose Rivaroxaban (VLDR) in addition to dual antiplatelet therapy improve thrombotic status in acute coronary syndrome (VaLiDate-R)" study : A randomised trial modulating endogenous fibrinolysis in patients with acute coronary syndrome.

ABSTRACT: 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.

SUBMITTER: Gue YX

PROVIDER: S-EPMC6969858 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Rationale and design of "Can Very Low Dose Rivaroxaban (VLDR) in addition to dual antiplatelet therapy improve thrombotic status in acute coronary syndrome (VaLiDate-R)" study : A randomised trial modulating endogenous fibrinolysis in patients with acute coronary syndrome.

Gue Ying X YX Kanji Rahim R Wellsted David M DM Srinivasan Manivannan M Wyatt Solange S Gorog Diana A DA

Journal of thrombosis and thrombolysis 20200201 2

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-ri ...[more]

PMID: 31872349

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Project description:BackgroundOral anticoagulation in addition to antiplatelet treatment after an acute coronary syndrome might reduce ischaemic events but increase bleeding risk. We performed a meta-analysis to evaluate the efficacy and safety of adding direct thrombin or factor-Xa inhibition by any of the novel oral anticoagulants (apixaban, dabigatran, darexaban, rivaroxaban, and ximelagatran) to single (aspirin) or dual (aspirin and clopidogrel) antiplatelet therapy in this setting.Methods and resultsAll seven published randomized, placebo-controlled phase II and III studies of novel oral anticoagulants in acute coronary syndromes were included. The database consisted of 30 866 patients, 4135 (13.4%) on single, and 26 731 (86.6%) on dual antiplatelet therapy, with a non-ST- or ST-elevation acute coronary syndrome within the last 7-14 days. We defined major adverse cardiovascular events (MACEs) as the composite of all-cause mortality, myocardial infarction, or stroke; and clinically significant bleeding as the composite of major and non-major bleeding requiring medical attention according to the study definitions. When compared with aspirin alone the combination of an oral anticoagulant and aspirin reduced the incidence of MACE [hazard ratio (HR) and 95% confidence interval 0.70; 0.59-0.84], but increased clinically significant bleeding (HR: 1.79; 1.54-2.09). Compared with dual antiplatelet therapy with aspirin and clopidogrel, adding an oral anticoagulant decreased the incidence of MACE modestly (HR: 0.87; 0.80-0.95), but more than doubled the bleeding (HR: 2.34; 2.06-2.66). Heterogeneity between studies was low, and results were similar when restricting the analysis to phase III studies.ConclusionIn patients with a recent acute coronary syndrome, the addition of a new oral anticoagulant to antiplatelet therapy results in a modest reduction in cardiovascular events but a substantial increase in bleeding, most pronounced when new oral anticoagulants are combined with dual antiplatelet therapy.

Project description:PurposeTo assess the effect of acute coronary syndrome (ACS) patients' education on their adherence to dual antiplatelet therapy (DAPT) and on lifestyle modifications.MethodsPatients who were prescribed acetyl salicylic acid and clopidogrel DAPT within 15 days of having an ACS event were enrolled in this study. Patients were randomized into two arms: the first arm received the study intervention, which consisted of education on coronary artery disease and the importance of sustained platelet inhibition, whereas the second arm was the control group. Both arms received education on lifestyle modifications. Patients completed six visits over 1 year. At each visit, pill count was used to assess adherence to DAPT, data on lifestyle modifications were collected, and changes in weight and waist circumference were recorded. Cardiovascular risk factors were recorded at baseline and the occurrence of new events was monitored throughout the study.ResultsThere were 153 patients in Arm 1 and 168 in Arm 2. At Month 6, 99.3% of patients in Arm 1 were adherent compared with 94.4% in Arm 2 (p = 0.016). At Month 12, 303 (94.4%) patients from the overall population were adherent to DAPT and there was no significant difference between the two arms (p = 0.443). In addition, no statistically significant difference was found in mean change in weight (3 kg vs. 2 kg, p = 0.064) or mean change in waist circumference (3.5 cm vs. 2.6 cm, p = 0.071) between the two arms. There was a significant decrease in the percentage of smokers (p < 0.001) and a significant increase in the percentage of physically active patients (p < 0.001) within each arm between baseline and Month 12, but the percent change in smokers (z = 1.72, p = 0.085) and percent change in physically active patients (z = 0.76, p = 0.447) between the two arms were not significantly different. Fourteen myocardial infarctions and two strokes occurred throughout the study period.ConclusionPatient education on DAPT showed short-term effect on adherence to treatment. More effective education methods should be developed to improve long-term DAPT adherence.

Dataset Information

Rationale and design of "Can Very Low Dose Rivaroxaban (VLDR) in addition to dual antiplatelet therapy improve thrombotic status in acute coronary syndrome (VaLiDate-R)" study : A randomised trial modulating endogenous fibrinolysis in patients with acute coronary syndrome.

Publications

Rationale and design of "Can Very Low Dose Rivaroxaban (VLDR) in addition to dual antiplatelet therapy improve thrombotic status in acute coronary syndrome (VaLiDate-R)" study : A randomised trial modulating endogenous fibrinolysis in patients with acute coronary syndrome.

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