Tecarfarin Anti-Coagulation Trial (TACT)

NCT02522221 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: CLN-511
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

TACT is a "real world" randomized controlled trial of tecarfarin, a novel vitamin K antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two groups of subjects who require chronic oral anticoagulation for a broad panel of indications.

Conditions

Thromboembolism; Thrombosis

Keywords

chronic anticoagulation; vitamin K antagonist; mechanical heart valve; CYP2C9; warfarin; tecarfarin; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Percentage of time in the therapeutic range (TTR) for tecarfarin vs. warfarin for each treatment group in the randomized population

  Interpolated and observed TTR will be calculated for the two treatment groups

  From the date of randomization until study termination, up to 24 months (1st month not included)

Secondary Outcomes (5)

• Percentage TTR for tecarfarin vs. warfarin in the sub-population of patients who are taking a CYP2C9-interacting medication and have a CYP2C9 genotype variant allele

  From the date of randomization until study termination, up to 24 months (1st month not included)

• Percentage TTR for tecarfarin vs warfarin for the sub-population of patients who are taking a CYP2C9-interacting medication and have chronic kidney disease stage 3 or 4 (eGFR ≥ 15 to <60 mL/min/1.73 m2)

  From the date of randomization until study termination, up to 24 months (1st month not included)

• Percentage of patients with INR > 4.0 for tecarfarin vs. warfarin

  From the date of randomization until study termination, up to 24 months (1st month not included)

• Percentage of patients with INR > 5.0

  From the date of randomization until study termination, up to 24 months (1st month not included)

• Time to first embolic event for tecarfarin vs. warfarin

  From the date of randomization until study termination, up to 24 months

Other Outcomes (2)

• The primary safety endpoint of this study is the time to the first BARC category 3-5 bleeding event.

  From the date of randomization until study termination, up to 24 months

• The secondary safety endpoint of this study is the time to the first BARC category 2-5 bleeding event

  From the date of randomization until study termination, up to 24 months

Study Arms (2)

Tecarfarin

EXPERIMENTAL

Tecarfarin will be administered and dose adjusted by the investigator. Dose adjustments will be made in accordance with a target INR range pre-specified by the investigator.

Drug: tecarfarin

Warfarin

ACTIVE COMPARATOR

Warfarin will be administered and dose adjusted by the investigator. Dose adjustments will be made in accordance with a target INR range pre-specified by the investigator.

Drug: Warfarin

Interventions

Warfarin DRUG

Warfarin is an oral vitamin K antagonist anticoagulant.

Also known as: Coumadin

Warfarin

tecarfarin DRUG

Tecarfarin is an oral vitamin K antagonist anticoagulant

Also known as: ATI-5923

Tecarfarin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female and at least 18 years of age.
• Is able and willing to sign an IRB-approved written informed consent.
• Is able and willing to follow instructions, to comply with protocol requirements, and to attend required study visits.
• Is taking a CYP2C9-interacting medication (inhibitor, substrate, or inducer; see list in Appendix A) at the time of randomization and is expected to receive this medication chronically for the duration of the trial.
• Has either
• Chronic kidney disease stage 3 or 4 (eGFR ≥ 15 to \<60 mL/min/1.73 m2 at Screening based on central laboratory) and/or
• A CYP2C9 genotype variant allele
• Requires chronic anticoagulation therapy.
• Is willing to receive chronic anticoagulation investigational therapy for the duration of the study or, for warfarin-naïve DVT subjects, treating physician prescribed at least a 6-month treatment period with an oral anticoagulation agent.
• Has one or more of the following indications for chronic oral anticoagulation:
• Atrial fibrillation/flutter (paroxysmal, persistent or permanent), not due to a reversible cause, documented by electrocardiography (ECG)
• Aortic and/or mitral prosthetic HV
• History of venous thromboembolic disease
• History of myocardial infarction or cardiomyopathy
• Any another indication for which warfarin is approved or recommended, with Sponsor approval

You may not qualify if:

• Is pregnant, nursing, or a woman of childbearing potential who cannot assure that they will not become pregnant for the duration of the study.
• Has been treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, at time of screening.
• Has a life expectancy \<1 year
• Is age \>85 years
• Has severe end-organ disease, such as:
• Estimated GFR (eGFR) \< 15 mL/min/1.73 m2 at Screening per the central laboratory
• Is on dialysis
• Is expected to be on dialysis or receive kidney transplant within 6 months of screening
• Advanced pulmonary disease requiring home oxygen
• NYHA class IV heart failure
• Severe psychiatric disorder such as advanced dementia
• Has a history of ischemic stroke without residual neurologic deficit within the last 3 months, prior major ischemic stroke with residual neurologic deficit, or any history of intracranial bleeding
• Is an ongoing alcohol or substance abuser
• Has anemia (screening hemoglobin \<9 g/dL) For subjects who have received a MHV within 4 weeks of Screening, who have no active bleeding, and whose hemoglobin is stable, a Screening hemoglobin as low as 8 g/dL is allowed.
• For subjects with severe CKD (eGFR ≥ 15 to \<30 mL/min/1.73 m2), who have no active bleeding, and whose hemoglobin is stable, a Screening hemoglobin as low as 8 g/dL is allowed.

Sponsors & Collaborators

• Espero Biopharma: lead

MeSH Terms

Conditions

Thromboembolism; Thrombosis; Renal Insufficiency, Chronic

Interventions

Warfarin; tecarfarin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 13, 2015
• Study Start: June 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: July 1, 2019
• Last Updated: January 25, 2018

Record last verified: 2018-01