Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS
VaLiDate-R
1 other identifier
interventional
150
1 country
1
Brief Summary
A prospective, randomised, open label study of 3 clinically licensed treatments for ACS to assess the effects of these treatments on blood tests of endogenous fibrinolysis. 50 patients will be randomised to each of the 3 treatment arms in 1:1:1 ratio. Patients will receive the randomised treatment for 1 month after their index admission with ACS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedStudy Start
First participant enrolled
January 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 12, 2020
February 1, 2020
2.9 years
December 12, 2018
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 30 days
To investigate, in patients with recent acute coronary syndrome and who have impaired endogenous fibrinolysis, whether the addition of low dose rivaroxaban to DAPT can improve endogenous thrombotic and fibrinolytic status
30 days
Secondary Outcomes (2)
Frequency of further angioplasty
6 months
Frequency of further heart attack, stroke or death
6 months
Study Arms (3)
Clopidogrel with Rivaroxaban
EXPERIMENTALClopidogrel 75mg o.d. and Rivaroxaban 2.5mg b.i.d.
Clopidogrel
ACTIVE COMPARATORClopidogrel 75mg o.d.
Ticagrelor
ACTIVE COMPARATORTicagrelor 90mg b.i.d.
Interventions
Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel
Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel)
Prevention of atherothrombotic events in patients with acute coronary syndrome \[in combination with aspirin\]
Eligibility Criteria
You may qualify if:
- Male and female patients aged 18 years or over
- Have a diagnosis of acute coronary syndrome requiring treatment with dual antiplatelet therapy
- Be willing and able to understand the Participant Information Sheet and provide informed consent
- Agree to comply with the drawing of blood samples for the assessments
You may not qualify if:
- Male and female participants aged \< 18 years of age.
- Patient unwilling or unable to give informed consent
- Patients who might be pregnant or are breast-feeding
- Active clinically significant bleeding
- Patient who, in the opinion of the investigator, has condition considered to be a significant risk for major bleeding (such as current or recent gastrointestinal ulceration, presence of malignant neoplasm at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities)
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
- Patient with any contraindications to use of antiplatelet agents or anticoagulants
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Summary of Product Characteristics (SmPC) of Rivaroxaban
- Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban etc.) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
- Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA)
- Patient with ongoing active alcohol or substance abuse or demonstrates signs or clinical features of active substance abuse.
- Patient with any major bleeding diathesis or blood dyscrasia at baseline (platelets\<70 x 109/l, Hb\<80 g/l, INR\>1.4, APTT\> x 2UNL, leucocyte count\< 3.5x 109/l, neutrophil count\<1x 109/l)
- Patient currently enrolled in an investigational drug trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Related Publications (1)
Gue YX, Kanji R, Wellsted DM, Srinivasan M, Wyatt S, Gorog DA. 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. J Thromb Thrombolysis. 2020 Feb;49(2):192-198. doi: 10.1007/s11239-019-02014-5.
PMID: 31872349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2018
First Posted
December 14, 2018
Study Start
January 8, 2019
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share