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INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority (INVICTUS-ASA)

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ClinicalTrials.gov Identifier: NCT02832531
Recruitment Status : Not yet recruiting
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke.

A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.


Condition or disease Intervention/treatment Phase
Rheumatic Heart Disease Drug: Rivaroxaban (15 mg) Drug: Aspirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
Study Start Date : December 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: Rivaroxaban (15 mg)
Rivaroxaban 15 mg od (n ~ 1000)
Drug: Rivaroxaban (15 mg)

Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following:

  1. Left atrial enlargement ≥ 5.5 cm, OR
  2. Left atrial spontaneous echo contrast OR
  3. Left atrial thrombus OR
  4. Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG.
Other Name: Xarelto

Active Comparator: Aspirin (ASA)
Aspirin 100 mg od (n~1000)
Drug: Aspirin
Other Name: acetylsalicylic acid




Primary Outcome Measures :
  1. Time from randomization to the first occurrence of Stroke or systemic embolism [ Time Frame: Approximately 4 years ]
    Stroke (Ischemic, hemorrhagic or undetermined type)


Secondary Outcome Measures :
  1. Time from randomization to the first occurrence of Myocardial Infarction (MI) [ Time Frame: Approximately 4 years ]
  2. Time from randomization to time of vascular death [ Time Frame: Approximately 4 years ]
    Vascular death includes death due to stroke, myocardial infarction, heart failure or cardiogenic shock, sudden death or any other death due to cardiovascular causes. In addition, death due to hemorrhage will be included


Other Outcome Measures:
  1. Time from randomization to the first occurrence of a Major bleed [ Time Frame: Approximately 4 years ]
    Using the International Society on Thrombosis and Haemostasis (ISTH) major bleeding definition



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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. RVHD diagnosed by echocardiography at any time prior to enrollment
  2. Age ≥18
  3. Increased risk of stroke by any of the following

    1. CHA2DS2-VASc score ≥ 2 OR
    2. Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR
    3. Left atrial spontaneous echo contrast OR
    4. Left atrial thrombus
  4. Heart Rhythm

    1. AF or Flutter and unsuitable for VKA therapy. (AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram). OR
    2. In the absence of AF or Flutter, patients would be eligible in the presence of any one of the following:
    1. Left atrial enlargement ≥5.5 cm OR
    2. Left atrial spontaneous echo contrast OR
    3. Left atrial thrombus OR
    4. Frequent ectopic atrial activity (>1000/24 hours) on Holter monitoring

Exclusion Criteria:

  1. Refusal to give informed consent
  2. Actively involved in any study that would compromise the protocol of INVICTUS Trial
  3. Severe co-morbid condition with life expectancy < 1 year
  4. Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
  5. Likely to have valve replacement surgery within 6 months
  6. Mechanical valve prosthesis or other condition requiring treatment with VKAs. Patients with deep vein thrombosis or recent pulmonary embolism can be enrolled where both VKAs and rivaroxaban are approved.
  7. Contraindication to the study medication of the trial

    • Allergy to rivaroxaban
    • Allergy to VKAs ( non-inferiority trial)
    • Allergy to aspirin ( superiority trial)
  8. Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) <15 ml/min
  9. Serious bleeding in the past six months or at high risk for bleeding
  10. Moderate to severe hepatic impairment
  11. Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded)
  12. Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.
  13. Received an investigational drug in the past 30 days
  14. Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits
  15. Women who are pregnant and/or breastfeeding
  16. Women of child bearing age who do not use an effective form of birth control.

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02832531     History of Changes
Other Study ID Numbers: INVICTUS - ASA
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: cumulative participant data only

Keywords provided by Population Health Research Institute:
atrial fibrillation
stroke

Additional relevant MeSH terms:
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Heart Diseases
Rheumatic Diseases
Rheumatic Heart Disease
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Aspirin
Rivaroxaban
Vitamin K
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