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NCT02145546: ADA-PAF
Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
Phase 4 trial testing Amiodarone in Atrial Fibrillation in 600 participants. Status unknown.
1 May 2017
Quick facts
| Lead sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 600 |
| Start date | 1 May 2014 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 May 2017 |
| Sites | 1 location across China |
Drugs / interventions tested
- Amiodarone (AMIODARONE) — full drug profile →
- Propafenone — full drug profile →
- Sotalol (sotalol) — full drug profile →
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Average AF burden in minutes per day
Time frame: monthly up to 12 months
Long term usages of test drug reduce AF burden, including the number and accumulated total time of AF per day. -
Persistent AF free survival rate
Time frame: monthly up to12 months
Long term usages of test drugs reduce the occurence of the persistent AF ( the persistent AF survival rate)。
Sponsor's own description
The current evidences indicate that \~30% patients with sick sinus syndrome(SSS) would develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including the reduced AF burden (duration and episodes) and persistent AF free survival rate. All patients will be followed up for 12 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02145546
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT05287191 — MAGNAM Trial, Magnesium Versus Amiodarone in Atrial Fibrillation in Critical Care · Phase 3 · recruiting
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Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
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Other Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02145546 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 20 May 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02145546.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing