Rivaroxaban or Aspirin for Biological Aortic Prosthesis

NCT02974920 | Unknown Phase 4 DMC

• 1 other identifier: 2016-002291-27
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 4

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

Conditions

Aortic Stenosis; Aortic Regurgitation; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Combined: Death, Stroke, Myocardial infarction

  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.

  6 months

Secondary Outcomes (4)

• Fatal or non fatal thrombotic event

  6 months

• Cardiovascular Mortality

  6 months

• Bleeding

  6 months

• Reduced leaflet motion

  3 months

Study Arms (2)

Aspirin 100 mg

ACTIVE COMPARATOR

100 mg of aspirin daily for 180 days

Drug: Aspirin

Rivaroxaban 10 mg

ACTIVE COMPARATOR

10 mg of Rivaroxaban daily for 180 days

Drug: Rivaroxaban 10 MG

Interventions

Rivaroxaban 10 MG DRUG

Rivaroxaban 10 mg once daily for 180 days

Rivaroxaban 10 mg

Aspirin DRUG

Aspirin 100 mg once daily for 180 days

Aspirin 100 mg

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years scheduled for surgical bioprosthetic aortic valve replacement.
• Ability to understand the study background, risk and benefit of treatment and to give written informed consent
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Christian Torp-Pedersen: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (4)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency; Thrombosis

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Christian Torp-Pedersen, MD

CONTACT

+45 24453790; ctp@heart.dk

Lone Hansen, Secretary

CONTACT

+45 99409637; lbh@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 29, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

DK (4)