Dexamethasone Compared to Conventional Therapy in the Treatment of Acute Pericarditis (Dexa-P)
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|ClinicalTrials.gov Identifier: NCT04323280|
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : March 31, 2020
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 conventional therapy in the treatment of acute pericarditis with less potential side effects compared to conventional therapy.
The Investigators aim to conduct a randomised, non-blinded trial assessing the use of dexamethasone as an alternative to conventional therapy for use in patients with acute pericarditis.
|Condition or disease||Intervention/treatment||Phase|
|Pericarditis Acute||Drug: Dexamethasone therapy Drug: Conventional Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||538 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised, non-blinded trial|
|Masking:||None (Open Label)|
|Official Title:||Dexamethasone Compared to Conventional Therapy in the Treatment of Acute Pericarditis: a Superiority Randomized Controlled Trial (Dexa-P)|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Active Comparator: Conventional Therapy
a. NSAIDs therapy
i. Ibuprofen 600mg every 8 hours for one week followed by tapering of dose by 200mg every week (3 weeks of therapy)
ii. Aspirin 800mg every 8 hours for one week followed by tapering of dose by 300mg each week (3 weeks of therapy)
b. Or Glucocorticoid Therapy (if contra-indication to NSAIDS):
i. Prednisone 0.2-0.5mg/kg/day for one week with gradual tapering.
c. All regimens are with added Colchicine 0.5mg daily (<70kg) or 0.5mg twice daily (>70kg) for 3 months
Drug: Conventional 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
- 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:
- Pericardial friction rub
- Electrocardiographic changes specific to pericarditis (concave ST elevation, PR depression)
- Echocardiographic evidence of pericardial effusion
- 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.
- 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
- Disease-related re-hospitalization [ Time Frame: 12 months ]Number of participants in each arm that are hospitalization due to recurrent pericarditis
- Occurrence of new onset Atrial Fibrillation [ Time Frame: 12 months ]Incidence of new onset atrial fibrillation in each arm
- Cardiac Tamponade [ Time Frame: 1 month ]Number of participants that develop cardiac tamponade in each arm
- Constrictive Pericarditis [ Time Frame: 12 months ]Number of participants that develop constrictive pericarditis in each arm
- 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
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
|Contact: Nili Schamroth Pravda, MbbChfirstname.lastname@example.org|
|Contact: Katia Orvin, MDemail@example.com|
|Study Chair:||Nili Schamroth Pravda, MbbCH||Rabin Medical Center|