Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis (Dexa-P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323280
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Pericarditis Acute Drug: Dexamethasone therapy Drug: NSAID therapy Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, non-blinded trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis: a Non-inferiority Randomized Controlled Trial (Dexa-P)
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conventional Therapy
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
NSAIDS (Ibuprofen or Aspirin) or Glucocorticoid (Prednisone) therapy for 3 weeks with addional colchicine therapy for 3 months

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




Primary Outcome Measures :
  1. Occurrence of Recurrent Pericarditis within 12 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. The time to first recurrence [ Time Frame: 12 months ]
    Average number of days to first recurrence of pericarditis (as per definition above) in each arm

  2. Disease-related re-hospitalization [ Time Frame: 12 months ]
    Number of participants in each arm that are hospitalization due to recurrent pericarditis

  3. Occurrence of new onset Atrial Fibrillation [ Time Frame: 12 months ]
    Incidence of new onset atrial fibrillation in each arm

  4. Cardiac Tamponade [ Time Frame: 1 month ]
    Number of participants that develop cardiac tamponade in each arm

  5. Constrictive Pericarditis [ Time Frame: 12 months ]
    Number of participants that develop constrictive pericarditis in each arm

  6. Side effects during therapy [ Time Frame: During therapy (4 days or 3 weeks depending on arm of therapy) ]

    Number of Participants in each arm that experience:

    • Gastrointestinal Disorder during therapy : diarrhoea (>3 times in 24 hours), vomiting (>3 times in 24 hours) due to therapy
    • Renal dysfunction (An increase in serum creatine >1.5 times baseline which has occurred within 1 week of therapy)
    • Hyperkalaemia during therapy (> 6 mEq/l)
    • Development of Severe Hypertension during therapy - Diastolic Blood Pressure >110mmHg
    • Hyperglycaemia during therapy >200mg/dl
    • Bleeding Event during therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323280


Contacts
Layout table for location contacts
Contact: Nili Schamroth Pravda, MbbCh +972544476243 drnscham@gmail.com
Contact: Katia Orvin, MD +972548001942 katiaorvin@gmail.com

Sponsors and Collaborators
Rabin Medical Center
Investigators
Layout table for investigator information
Study Chair: Nili Schamroth Pravda, MbbCH Rabin Medical Center
Layout table for additonal information
Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04323280    
Other Study ID Numbers: RMC-0543-19
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rabin Medical Center:
Dexamethasone
Additional relevant MeSH terms:
Layout table for MeSH terms
Pericarditis
Heart Diseases
Cardiovascular Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents