Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis

NCT04323280 | Terminated Phase 4

• 1 other identifier: RMC-0543-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of acute pericarditis is empiric and is based on treatment with medications with anti-inflammatory properties such as non-steroidal anti-inflammatory drugs (NSAID) and corticosteroids. However, this therapy is given as a relatively long course of therapy (≥ 3 weeks) and can be associated with substantial side effects. Dexamethasone is a potent corticosteroid that has not been investigated an alternative to conventional therapy in patients with acute pericarditis. Dexamethasone is an inexpensive drug and can be given in an oral tablet form. It has a quick onset of action, relatively long duration of action and is therefore often given in high doses for short periods. Dexamethasone has been shown to be a safe therapeutic option in ITP (Immune Thrombocytopenia), another disease in which steroids are an accepted treatment option. The abundant data on using dexamethasone in comparison to longer prednisone-based regimens has been evaluated in this disease and has shown to be effective and without the longer exposure time to steroids and potential side effects. This data shows that dexamethasone can be a safe therapeutic option. The investigators hypothesize that therapy with short term, high dose dexamethasone will offer better clinical responses to NSAID therapy in the treatment of acute pericarditis with less potential side effects compared to NSAID therapy. The Investigators aim to conduct a randomised, non-blinded trial assessing the use of dexamethasone as an alternative to NSAID for use in patients with acute pericarditis.

Conditions

Pericarditis Acute

Keywords

Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Occurrence of Recurrent Pericarditis within 12 months

  Definition of Recurrent Pericarditis: Recurrence of pleuritic chest pain and one or more of the following signs: 1. Pericardial friction rub 2. Electrocardiographic changes specific to pericarditis (concave ST elevation, PR depression) 3. Echocardiographic evidence of pericardial effusion 4. An elevation in inflammatory markers (white-cell count,or C-reactive protein level) with a symptom-free interval of 6 weeks or longer after the first acute event.

  12 months

Secondary Outcomes (6)

• The time to first recurrence

  12 months

• Disease-related re-hospitalization

  12 months

• Occurrence of new onset Atrial Fibrillation

  12 months

• Cardiac Tamponade

  1 month

• Constrictive Pericarditis

  12 months

Study Arms (2)

Conventional Therapy

ACTIVE COMPARATOR

Ibuprofen 600mg every 8 hours for one week followed by tapering of dose by 200mg every week (3 weeks of therapy), in addition to Colchicine 0.5mg daily (\<70kg) or 0.5mg twice daily (\>70kg) for 3 months

Drug: NSAID therapy

Dexamethasone therapy

EXPERIMENTAL

Dexamethasone therapy 20 mg once daily per os for 4 day in addition to colchicine therapy for 3 months 0.5mg daily (\<70kg) or 0.5mg twice daily (\>70kg)

Drug: Dexamethasone therapy

Interventions

Dexamethasone therapy DRUG

Dexamethasone 20MG once daily for 4 days with additional colchicine therapy for 3 months

Dexamethasone therapy

NSAID therapy DRUG

NSAIDS (Ibuprofen or Aspirin) or Glucocorticoid (Prednisone) therapy for 3 weeks with addional colchicine therapy for 3 months

Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with first presentation of acute pericarditis (both idiopathic and post pericardiectomy)
• Patients diagnosed according to accepted clinical findings: 2 of the 4 following criteria: chest pain, pericardial friction rub, ECG changes typical for pericarditis and/or pericardial effusion.
• Patients over the age of 18 years

You may not qualify if:

• Patient with Uncontrolled Diabetes (as defined as hyperglycaemia \>300mg/dl at presentation or HBA1C\>9% (if known))
• Patients with a known allergy to steroid therapy
• Patient with a known allergy to NSAID therapy
• Patients with a known contraindication to colchicine therapy
• Pregnancy or lactating women
• Patients with systemic fungal infection
• Patients with a known pericardial effusion of tuberculous, purulent, or neoplastic causes
• Patients with chronic steroid use
• Patients with a known rheumatological disease

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 1234, Israel

Location

Study Officials

• Nili Schamroth Pravda, MbbCH

  Rabin Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, non-blinded trial

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: February 14, 2020
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)