NCT03273322

Brief Summary

Evaluation of 2 doses of rivaroxaban (10 and 15 mg) compared to dual anti platelet therapy (aspirin+clopidogrel) after left atrial appendage closure. The patients will be assessed at 10 and 90 days: central laboratory hemostasis analysis and clinical events assessment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_2 atrial-fibrillation

Timeline
Completed

Started Sep 2017

Typical duration for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

September 13, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

December 21, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

August 11, 2017

Last Update Submit

December 20, 2021

Conditions

Atrial FibrillationAtrial AppendageHemorrhage

Keywords

Left atrial appendage closureRivaroxabanDual antiplatelet therapyAnticoagulationStroke prevention

Outcome Measures

Primary Outcomes (1)

  • Measure of prothrombin fragment 1 + 2

    Measure of prothrombin fragment 1 + 2 at Day 10 (2 to 4 hours after last intake : concentration peak)

    at Day 10

Secondary Outcomes (20)

  • Measure of prothrombin fragment 1 + 2

    at Day 90

  • Factor Xa inhibitory activity at day 10

    at Day 10

  • Factor Xa inhibitory activity at day 90

    at Day 90

  • Russel Viper venom enzyme assay

    at Day 90

  • TAT complex

    at Day 10

  • +15 more secondary outcomes

Study Arms (3)

1: Rivaroxaban 10 mg qd

EXPERIMENTAL

Rivaroxaban 10 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM

Drug: Rivaroxaban 10 mg qd

2: Rivaroxaban 15 mg qd

EXPERIMENTAL

Rivaroxaban 15 mg, 1 tablet a day, from randomization to Day 90 should be taken between 8 and 10 AM

Drug: Rivaroxaban 15 mg qd

3: DAPT

ACTIVE COMPARATOR

Aspirin 75 mg, 1 a day Clopidogrel 75 mg, 1 tablet a day from randomization to Day 90 should be taken between 8 and 10 AM

Drug: DAPT

Interventions

Rivaroxaban 10 mg qdDRUG

10mg qd

Also known as: Experimental
1: Rivaroxaban 10 mg qd
Rivaroxaban 15 mg qdDRUG

15mg qd

Also known as: Experimental
2: Rivaroxaban 15 mg qd
DAPTDRUG

Aspirin 75 mg qd + Clopidogrel 75 mg qd

Also known as: Active comparator
3: DAPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥18 years of age
  • Patients who underwent a clinically successful LAAC procedure (device implanted without procedural or bleeding complication). LAAC may have been indicated for patients contraindicated or unsuitable for long-term Vitamin K antagonists (VKA) anticoagulation.
  • AF (permanent or persistent or paroxysmal) patients irrespective of prior antithrombotic treatment are eligible for randomization.
  • Written informed consent by the patient or designee if the patient is unable to consent
  • Patients affiliated to the French social security system

You may not qualify if:

  • Creatinine clearance \<30 mL / min (Cockcroft formula).
  • Dialysis.
  • Mechanical heart valves or valvular disease requiring surgery or interventional procedure
  • Planned Ablation of AF during follow up period
  • Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk).
  • Any contra-indication or known allergy to aspirin or clopidogrel or rivaroxaban.
  • Any mandatory indication for anticoagulation for a reason other than AF (e.g. Pulmonary embolism)
  • Ongoing major bleeding or complicated or recent (\<72hours) major surgery
  • Known large oesophageal varices or decompensated liver disease (unless a documented positive opinion of a gastro-enterologist)
  • Severe thrombocytopenia (\<50,000/ml) after referral to haematologist to confirm or not contraindication
  • Recent myocardial infarction (\<6 weeks).
  • Recent cerebro-vascular event (CVE) or transient ischemic attack (\<6 weeks) after evaluation of stroke vs bleeding risk by the referring neurologist.
  • Recent Intracranial bleeding (\< 6 months): these patients will be evaluated by a neurologist as these patients may be considered at higher stroke risk. Neurologist may consider that the LAAC procedure with a short (90 days) period of anticoagulation or antiplatelet therapy as tested in the protocol is a preferable option (in that case intracranial hemorrhage (ICH) will not be considered as a contraindication).
  • Prasugrel or ticagrelor concomitant use
  • Participating in an investigational drug or another device trial within the previous 30 days.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cardiologie - Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • Duthoit G, Silvain J, Marijon E, Ducrocq G, Lepillier A, Frere C, Dimby SF, Popovic B, Lellouche N, Martin-Toutain I, Spaulding C, Brochet E, Attias D, Mansourati J, Lorgis L, Klug D, Zannad N, Hauguel-Moreau M, Braik N, Deltour S, Ceccaldi A, Wang H, Hammoudi N, Brugier D, Vicaut E, Juliard JM, Montalescot G. Reduced Rivaroxaban Dose Versus Dual Antiplatelet Therapy After Left Atrial Appendage Closure: ADRIFT a Randomized Pilot Study. Circ Cardiovasc Interv. 2020 Jul;13(7):e008481. doi: 10.1161/CIRCINTERVENTIONS.119.008481. Epub 2020 Jul 17.

    PMID: 32674675DERIVED

MeSH Terms

Conditions

Atrial FibrillationHemorrhage

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gilles MONTALESCOT, MD, PhD

    Centre Hospitalier Universitaire Pitié-Salpêtrière Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

September 6, 2017

Study Start

September 13, 2017

Primary Completion

November 20, 2018

Study Completion

September 30, 2019

Last Updated

December 21, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)