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Rivaroxaban or Aspirin for Biological Aortic Prosthesis

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ClinicalTrials.gov Identifier: NCT02974920
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : June 27, 2018
Sponsor:
Collaborators:
Aalborg Universitetshospital
Aarhus University Hospital
Odense University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Christian Torp-Pedersen, Aalborg Universitetshospital

Brief Summary:
Aortic valve replacement with a biological prosthesis is the most common valve surgery performed with about 1000 operations performed in Denmark each year. Further, the introduction of percutaneous stent valves will increase these types of replacements in the years to come. A biological valve is a foreign body prone to cause thrombus formation at least until the valve is covered with recipient endothelium. There are no conclusive studies of anticoagulation and the investigators have shown stroke to be a common complication. Guidelines have variably recommended aspirin or rivaroxaban for anticoagulation, and currently aspirin is the most common recommendation. In a register study, the investigators have shown that proper anticoagulation with warfarin is likely to be superior. There is a clear need for a large randomised study of aspirin versus anticoagulation for biological aortic valve replacement. This protocol describes a randomised study where 1000 patients will be randomised to receive either rivaroxaban or aspirin for 6 months following aortic valve replacement with a biological prosthesis. The primary efficacy endpoint is a combined event of all-cause mortality and hospitalisation for either acute myocardial infarction or stroke. This study has the power to settle a discussion of appropriate anticoagulation for this operation

Condition or disease Intervention/treatment Phase
Aortic Stenosis Aortic Regurgitation Thrombosis Drug: Rivaroxaban 10 MG Drug: Aspirin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Trial of Aspirin Versus Rivaroxaban After Replacement of the Aortic Valve With a Biological Valve Prosthesis
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Active Comparator: Aspirin 100 mg
100 mg of aspirin daily for 180 days
Drug: Aspirin
Aspirin 100 mg once daily for 180 days

Active Comparator: Rivaroxaban 10 mg
10 mg of Rivaroxaban daily for 180 days
Drug: Rivaroxaban 10 MG
Rivaroxaban 10 mg once daily for 180 days




Primary Outcome Measures :
  1. Combined: Death, Stroke, Myocardial infarction [ Time Frame: 6 months ]

    The primary outcome is a combination of all-cause mortality, hospital admission for stroke and hospital admission for myocardial infarction.

    The main outcomes of the study are examined after 6 months.



Secondary Outcome Measures :
  1. Fatal or non fatal thrombotic event [ Time Frame: 6 months ]
    Hospital admission or cause of death from Stroke, Myocardial infarction or peripheral arterial embolism

  2. Cardiovascular Mortality [ Time Frame: 6 months ]
    Death is classified as cardiovascular unless there are documented other causes

  3. Bleeding [ Time Frame: 6 months ]
    Bleeding requiring hospitalization of causing death

  4. Reduced leaflet motion [ Time Frame: 3 months ]
    The proportion of patients with at least one prosthetic leaflet with >50% motion reduction as assessed by cardiac 4DCT-scan



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≥ 18 years scheduled for surgical bioprosthetic aortic valve replacement.
  2. Ability to understand the study background, risk and benefit of treatment and to give written informed consent
  3. Scheduled for routine antithrombotic treatment after surgical valve replacement. Patient required to receive aspirin due to simultaneous by-pass operation are allowed in the study - to receive either aspirin alone or rivaroxaban in addition to aspirin.

Exclusion Criteria:

  1. Ongoing treatment with oral anticoagulants (warfarin, phenprocoumon or thrombin/factorXa oral anticoagulants).
  2. Indication for oral anticoagulation treatment even if currently not treated (e.g. chronic atrial fibrillation, recent deep vein thrombosis, recent pulmonary embolism)
  3. Indication for dual antiplatelet therapy (e.g. aspirin and ADP receptor inhibitor)
  4. Known intolerance to aspirin or rivaroxaban.
  5. Stroke within 6 months of study start.
  6. Concomitant therapy with systemic drugs that are strong inhibitors of both CYP 3A4 and P-gp (azole antimycotics such as ketoconazole and itraconazole or HIV protease inhibitors such as ritonavir)
  7. Concomitant therapy with drugs that are strong CYP 3A4 inducers (e.g. carbamazepine, phenytoin, rifampin, St. John's wort)
  8. Platelet count of less than 90,000 per cubic millimeter
  9. Preoperative anemia with hemoglobin <6mmol/l
  10. Creatinine clearance (Cockroft formula) <15 ml/min
  11. Clinically significant gastrointestinal bleeding within 3 months
  12. Previous intracranial hemorrhage;
  13. The presence of a severe or active bleeding disorder.
  14. Non-adherence to medications
  15. Pregnancy or risk of pregnancy. In women of childbearing age, an approved birth control must be ensured.

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): NCT02974920


Contacts
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Contact: Christian Torp-Pedersen, MD +45 24453790 ctp@heart.dk
Contact: Lone Hansen, Secretary +45 99409637 lbh@hst.aau.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Jan Andreassen, MD       jja@dcm.aau.dk   
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Steen L Nielsen, MD       Steen.lyager.nielsen@skejby.rm.dk   
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Peter S Olsen, MD       peter.skov.olsen@regionh.dk   
Odense University Hospital Recruiting
Odense, Denmark
Contact: Lars Riber, MD       Lars.riber@rsyd.dk   
Sponsors and Collaborators
Christian Torp-Pedersen
Aalborg Universitetshospital
Aarhus University Hospital
Odense University Hospital
Rigshospitalet, Denmark

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Responsible Party: Christian Torp-Pedersen, Professor, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT02974920     History of Changes
Other Study ID Numbers: 2016-002291-27
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Anticoagulants
Thrombosis
Aortic Valve Stenosis
Aortic Valve Insufficiency
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Aspirin
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors