Status:
UNKNOWN
Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS
Lead Sponsor:
East and North Hertfordshire NHS Trust
Collaborating Sponsors:
University of Hertfordshire
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 randomi...
Detailed Description
Heart attacks are caused by a blood clot occurring in a blood vessel (artery) which supplies blood to the heart. Such a clot can build up and block the blood flow, depriving part of the heart muscle o...
Eligibility Criteria
Inclusion
- 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
- Not meet any of the exclusion criteria below
Exclusion
- 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
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03775746
Start Date
January 8 2019
End Date
December 1 2021
Last Update
February 12 2020
Active Locations (1)
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1
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, United Kingdom, SG1 4AB