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Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS (VaLiDate-R)

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ClinicalTrials.gov Identifier: NCT03775746
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
University of Hertfordshire
Information provided by (Responsible Party):
East and North Hertfordshire NHS Trust

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Clopidogrel 75Mg Tablet Drug: Rivaroxaban 2.5Mg Tablet Drug: Ticagrelor 90Mg Tablet Phase 4

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 of oxygen and blood, causing transient or permanent damage to the heart muscle.

The standard treatment for a heart attack is two blood thinning medications combined, every day, to reduce the risk of further blood clots forming and to prevent another heart attack. The highest risk of another heart attack is in the next 30 days after the first heart attack.

However, despite two blood thinners combined, some patients still go on to have another clot (heart attack or stroke or death) and this can be life threatening. Earlier research has shown that through a blood test, it is possible to identify patients who remain at increased risk of further clots and who may benefit from further blood thinners to reduce the risk of further heart attack, stroke and death in the next 30 days.

The aim of this study is to test which of 3 blood thinning treatment options (all already in widespread clinical use) is best for patients to reduce further blood clots, in particular the addition of low dose rivaroxaban.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clopidogrel with Rivaroxaban
Clopidogrel 75mg o.d. and Rivaroxaban 2.5mg b.i.d.
Drug: Clopidogrel 75Mg Tablet
Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel
Other Name: EU/1/08/465/001

Drug: Rivaroxaban 2.5Mg Tablet
Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel)
Other Names:
  • EU/1/08/472/025-035
  • EU/1/08/472/041
  • EU/1/08/472/046-047

Active Comparator: Clopidogrel
Clopidogrel 75mg o.d.
Drug: Clopidogrel 75Mg Tablet
Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel
Other Name: EU/1/08/465/001

Active Comparator: Ticagrelor
Ticagrelor 90mg b.i.d.
Drug: Ticagrelor 90Mg Tablet
Prevention of atherothrombotic events in patients with acute coronary syndrome [in combination with aspirin]
Other Name: EU/1/10/655/007-011




Primary Outcome Measures :
  1. The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 30 days [ Time Frame: 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


Secondary Outcome Measures :
  1. Frequency of further angioplasty [ Time Frame: 6 months ]
    Clinical events including re-intervention

  2. Frequency of further heart attack, stroke or death [ Time Frame: 6 months ]
    Incidence of further major adverse cardiac events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients aged 18 years or over
  2. Have a diagnosis of acute coronary syndrome requiring treatment with dual antiplatelet therapy
  3. Be willing and able to understand the Participant Information Sheet and provide informed consent
  4. Agree to comply with the drawing of blood samples for the assessments
  5. Not meet any of the exclusion criteria below

Exclusion Criteria:

  1. Male and female participants aged < 18 years of age.
  2. Patient unwilling or unable to give informed consent
  3. Patients who might be pregnant or are breast-feeding
  4. Active clinically significant bleeding
  5. 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)
  6. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
  7. Patient with any contraindications to use of antiplatelet agents or anticoagulants
  8. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Summary of Product Characteristics (SmPC) of Rivaroxaban
  9. 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
  10. Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA)
  11. Patient with ongoing active alcohol or substance abuse or demonstrates signs or clinical features of active substance abuse.
  12. 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)
  13. Patient currently enrolled in an investigational drug trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775746


Contacts
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Contact: Diana A Gorog, MD, PhD, FRCP 01438 284 753 d.gorog@nhs.net
Contact: Ying X Gue, MBChB, MRCP 01438 284 753 y.gue@nhs.net

Locations
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United Kingdom
East and North Hertfordshire NHS Trust Recruiting
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Contact: Diana A Gorog    +44(0)1707 247512    d.gorog@nhs.net   
Contact: Ying Gue    +44(0)1438 284753    y.gue@nhs.net   
Sponsors and Collaborators
East and North Hertfordshire NHS Trust
University of Hertfordshire

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Responsible Party: East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT03775746     History of Changes
Other Study ID Numbers: RD2018-41
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anticoagulants
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Rivaroxaban
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors