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A Phase 3 trial to evaluate tecarfarin's superiority to warfarin in LVAD patients

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Trial Profile

A Phase 3 trial to evaluate tecarfarin's superiority to warfarin in LVAD patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2025

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At a glance

  • Drugs Tecarfarin (Primary) ; Warfarin
  • Indications Thromboembolism; Thrombosis
  • Focus Registrational; Therapeutic Use
  • Acronyms LVAD study; TECH-LVAD

Most Recent Events

  • 13 Mar 2025 According to Cadrenal Therapeutics media release, the company and its pharmaceutical Contract Development and Manufacturing Organization (CDMO) completed necessary operational readiness activities to supply clinical trial materials for this trial in compliance with current Good Manufacturing Practices (cGMP).
  • 13 Mar 2025 According to Cadrenal Therapeutics media release, the company had a Type D meeting with the USFDA on 3 Feb 2025, where FDA provided additional guidance on the design of a future Phase 3 trial of tecarfarin and has requested the Company to submit a study design synopsis and detailed clinical trial design for review.
  • 13 Mar 2025 According to Cadrenal Therapeutics media release, the company has entered into a Collaboration Agreement with Abbott on 4 March 2025, to support this trial.Under the agreement, Abbott will share the expertise obtained from the recent HeartMate 3 clinical trials and will support Cadrenal with trial design, site identification and trial awareness.

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