Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
Recruiting
Phase 3
Interventional Study
Myocarditis Acute
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Other
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About This Trial
Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of a 3-week ibuprofen tapering regimen compared to conventional analgesic treatment (acetaminophen) in patients with acute myocarditis and left ventricular ejection fraction ≥50%. The objective is to assess the reduction in late gadolinium enhancement on cardiac magnetic resonance imaging at 6-month…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Aged 18 years or older.
* Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular \>50%.
* Elevated troponin I/T (3 times above the upper limit of normal).
* Absence of acute heart failure.
* Absence of ischemic heart disease (r…
Contacts