Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis: a Non-inferiority Randomized Controlled Trial (Dexa-P)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Occurrence of Recurrent Pericarditis within 12 months
研究概览
简要总结
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.
详细描述
Dexamethasone compared to Non-steroidal anti-inflammatory drugs in the treatment of acute pericarditis: a non-inferiority randomized controlled trial (Dexa-P)
Objectives:
The investigators hypothesize that therapy with short term, high dose dexamethasone will offer better clinical responses to NSAID therapy with less potential side effects compared to conventional therapy
Trial design:
A randomised, non-blinded trial assessing the use of dexamethasone as an alternative to NSAID therapy for use in patients with acute pericarditis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: NSAID therapy (Drug)
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)
干预措施: Dexamethasone therapy (Drug)
结局指标
主要结局
Occurrence of Recurrent Pericarditis within 12 months
时间窗: 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.
次要结局
- 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)
- Side effects during therapy(During therapy (4 days or 3 weeks depending on arm of therapy))