deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT05039359

Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation (RESTORE-1)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm

Sponsor: InCarda Therapeutics, Inc.

Interventions FlecIH-103
Updated 8 times since 2021 Last updated: Oct 26, 2023 Started: Apr 26, 2022 Primary completion: May 22, 2023 Completion: May 22, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Limited efficacy upon blinded review

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A PHASE3 clinical study on Paroxysmal Atrial Fibrillation, this trial is terminated or withdrawn. The trial is conducted by InCarda Therapeutics, Inc. and has accumulated 8 data snapshots since 2022. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

~Oct 2021 – ~May 2022 · 7 months · monthly snapshotNot Yet Recruiting~May 2022 – ~Jan 2023 · 8 months · monthly snapshotRecruiting~Jan 2023 – ~Jul 2023 · 6 months · monthly snapshotRecruiting~Jul 2023 – ~Nov 2023 · 4 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 11 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Nov 2023 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Jul 2023 — Nov 2023 [monthly]

    Terminated PHASE3

    Status: RecruitingTerminated

Show 3 earlier versions
  1. Jan 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  2. May 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  3. Oct 2021 — May 2022 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • InCarda Therapeutics, Inc.
Data source: InCarda Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .