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Phase 3 study of Revacept

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Trial Profile

Phase 3 study of Revacept

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2024

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At a glance

  • Drugs Revacept (Primary)
  • Indications Acute coronary syndromes; Coronary artery disease; Stroke
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 07 Aug 2024 According to an advanceCor media release, the planned phase 3 study discussed with the FDA was designed together with Klaus Groschel, Mainz, Germany and Jeffrey Saver, University of California Los Angeles (UCLA). The study protocol was written in a combined effort with these outstanding experts in the field and now approved by the FDA in this Type C meeting.
  • 07 Aug 2024 According to an advanceCor media release, company presented the protocol for a pivotal phase 3 study in patients with symptomatic carotid artery stenosis suffering from a stroke during the last 8 days. Additional comments on details for the study protocol were discussed with the FDA. Key features of the phase 3 study protocol were agreed and accepted by the FDA as pivotal phase 3 study to enable market approval for Revacept in the prevention of recurrent stroke.
  • 25 Aug 2022 New trial record

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