Pericarditis AcutePhase 4Dexa-PNCT04323280
Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis
A Phase 4 study testing Dexamethasone therapy and NSAID therapy in people with Pericarditis Acute, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pericarditis Acute
- What is being tested?
- Dexamethasone therapy and NSAID therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Feb 2020to 17 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with a known pericardial effusion of tuberculous, purulent, or neoplastic causes
- Patients with chronic steroid use
- Patients with a known rheumatological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis: a Non-inferiority Randomized Controlled Trial (Dexa-P)
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.
Read more
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.
Read the detailed description
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.
Quality Assurance:
After the first 3 participants have been enrolled and completed a month of follow up, the preliminary findings will be forwarded to the quality control committee of the Helsinki Ethics Committee of Rabin Medical Center
Withdrawal of participants:
Participants are free to discontinue their participation in the study at any time and without prejudice to further treatment.
A participant may withdraw or be withdrawn from the study for the following reasons:
- Subject withdrew consent.
- Severe Adverse Event (As described below) Reasons for withdrawal will be documented. In cases of more than one reason for early withdrawal from the study, the most significant reason will be stated.
Replacement of withdrawn participants:
Withdrawn randomized participants will not be replaced.
Discontinuing or modifying allocated interventions:
If a participant has incessant pericarditis within one month of therapy:
- Participants in the dexamethasone arm will be given another cycle of dexamethasone therapy of 20mg for 4 days can be given. If there is a further persistence, prednisone therapy will then be initiated.
- Participants in the NSAID therapy arm will be changes to prednisone therapy
Definition of incessant 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) without a symptom-free interval of 6 weeks or longer after the first acute event.
If participant is hospitalized with a possible side effect, the treating physician will be notified to assess for modifying the participant allocation.
Concomitant care:
There are no prohibited concomitant medications. Participants should continue to take drugs for other co-morbidities as usual.
Participant Timeline:
The enrollment will be done within 72 hours of initial assessment. Each participant will undergo eligibility screen and suitable participants will receive informed consent. The allocation will be determined immediately after the participant will be found to be eligible and will be made randomly.
Once participants are identified with an initial episode of acute pericarditis and informed consent is given, an initial assessment will be done.
This will include baseline blood tests - including baseline liver and renal function tests, full blood count and C-reactive protein.
All participants will undergo echocardiographic imaging at baseline. There are two possible interventions: dexamethasone therapy or NSAID therapy. Participants will be followed up at 1 weeks, 1 month, 6 months and 12 months after treatment initiation.
The follow up will be telephonically at 1 week, 6 months and 12 months. At the 1 month follow up, clinical assessment, inflammatory marker and a repeat echocardiogram will be performed. A repeat echocardiogram will be performed at 12 months. This follow up will be at the pericardial disease clinic at Rabin Medical Center
Sample size:
Assuming a success rate 85% in the NSAIDS group and 87% in the Dexamethasone intervention group, with a margin of non-inferiority of 10%, the sample size calculated was 208. (Alpha = 0.05, beta=0.2). Noninferiority would be shown if the upper boundary of the 95% confidence interval was 10 percentage points or less. A 10 percentage-point noninferiority margin was considered to be an acceptable difference in recurrence rate.
Recruitment:
Investigators will include physicians in the emergency room and admission setting to help identify and recruit participants.
Methods: Data Collection, management and analysis
Enrollment:
First assessment including baseline variables and suitability of the participant to the study will be made during the enrollment, by the study coordinators.
In addition demographic and clinical characteristics will be recorded. The data will be collected during an interview of the participant or with assistance of the computerized medical records.
Furthermore, laboratory tests such as blood count, liver and kidneys functions and C reactive protein will be made and be recorded for each participant.
Interventions:
The type of intervention will be recorded by the study coordinators for each participant according to the allocation group.
Assessments of outcomes:
The primary outcome at each follow up, both telephonically and on clinical follow up The secondary outcomes will be assessed telephonically and using the medical computerized systems.
Data management:
All data regarding the participant's hospitalization: Baselines variables, interventions and glucose levels will be stored in secured excel documents for each study group.
Data regarding the participant's outcomes will be stored in a different secured excel documents for each study group.
The coding of the documents and the separation between the hospitalization and follow up period data is designated to ensure the investigator blinding.
Statistical analysis:
The primary outcome is the occurrence of Recurrent Pericarditis within 12 months. This will be calculated by bivariate analysis as relative risk. The secondary outcome of time to recurrence will be plotted using Kaplan-Meier curves and compared using the Log-rank test (unadjusted analysis), Hazard ratio for the risk of the primary analysis between the control and Dexamethasone arm will be calculated using a univariate cox proportional hazards ratio model (unadjusted analysis). Further secondary outcomes will be analysed by bivariate analysis.
Methods: monitoring Harms: Side effects will be monitoring during therapy as defined
- Conditions
- Pericarditis Acute
- Being tested
- Dexamethasone therapy, NSAID therapy
- Keywords
- Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone therapyDrug
Dexamethasone 20MG once daily for 4 days with additional colchicine therapy for 3 months
NSAID therapyDrug
NSAIDS (Ibuprofen or Aspirin) or Glucocorticoid (Prednisone) therapy for 3 weeks with addional colchicine therapy for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Dexamethasone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Recurrent Pericarditis within 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.
Measured: 12 months
Secondary outcomes (6)
The time to first recurrence
Average number of days to first recurrence of pericarditis (as per definition above) in each arm
Measured: 12 months
Disease-related re-hospitalization
Number of participants in each arm that are hospitalization due to recurrent pericarditis
Measured: 12 months
Occurrence of new onset Atrial Fibrillation
Incidence of new onset atrial fibrillation in each arm
Measured: 12 months
Cardiac Tamponade
Number of participants that develop cardiac tamponade in each arm
Measured: 1 month
Constrictive Pericarditis
Number of participants that develop constrictive pericarditis in each arm
Measured: 12 months
Side effects during 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
Measured: During therapy (4 days or 3 weeks depending on arm of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start14 Feb 2020
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Why it stopped: Difficulty in enrollment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericarditis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, non-blinded trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nili Schamroth Pravda, MbbCH, Study chair, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323280
- Sponsor's protocol ID
- RMC-0543-19
- Acronym
- Dexa-P
- Status last verified
- Dec 2023
- First submitted
- 24 Mar 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis: a Non-inferiority Randomized Controlled Trial (Dexa-P)
- ClinicalTrials.gov ID
- NCT04323280
- Acronym / sponsor ID
- Dexa-P / RMC-0543-19
- Conditions
- Pericarditis Acute
- Keywords
- Dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrollment of patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Quality Assurance:
After the first 3 participants have been enrolled and completed a month of follow up, the preliminary findings will be forwarded to the quality control committee of the Helsinki Ethics Committee of Rabin Medical Center
Withdrawal of participants:
Participants are free to discontinue their participation in the study at any time and without prejudice to further treatment.
A participant may withdraw or be withdrawn from the study for the following reasons:
- Subject withdrew consent.
- Severe Adverse Event (As described below) Reasons for withdrawal will be documented. In cases of more than one reason for early withdrawal from the study, the most significant reason will be stated.
Replacement of withdrawn participants:
Withdrawn randomized participants will not be replaced.
Discontinuing or modifying allocated interventions:
If a participant has incessant pericarditis within one month of therapy:
- Participants in the dexamethasone arm will be given another cycle of dexamethasone therapy of 20mg for 4 days can be given. If there is a further persistence, prednisone therapy will then be initiated.
- Participants in the NSAID therapy arm will be changes to prednisone therapy
Definition of incessant 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) without a symptom-free interval of 6 weeks or longer after the first acute event.
If participant is hospitalized with a possible side effect, the treating physician will be notified to assess for modifying the participant allocation.
Concomitant care:
There are no prohibited concomitant medications. Participants should continue to take drugs for other co-morbidities as usual.
Participant Timeline:
The enrollment will be done within 72 hours of initial assessment. Each participant will undergo eligibility screen and suitable participants will receive informed consent. The allocation will be determined immediately after the participant will be found to be eligible and will be made randomly.
Once participants are identified with an initial episode of acute pericarditis and informed consent is given, an initial assessment will be done.
This will include baseline blood tests - including baseline liver and renal function tests, full blood count and C-reactive protein.
All participants will undergo echocardiographic imaging at baseline. There are two possible interventions: dexamethasone therapy or NSAID therapy. Participants will be followed up at 1 weeks, 1 month, 6 months and 12 months after treatment initiation.
The follow up will be telephonically at 1 week, 6 months and 12 months. At the 1 month follow up, clinical assessment, inflammatory marker and a repeat echocardiogram will be performed. A repeat echocardiogram will be performed at 12 months. This follow up will be at the pericardial disease clinic at Rabin Medical Center
Sample size:
Assuming a success rate 85% in the NSAIDS group and 87% in the Dexamethasone intervention group, with a margin of non-inferiority of 10%, the sample size calculated was 208. (Alpha = 0.05, beta=0.2). Noninferiority would be shown if the upper boundary of the 95% confidence interval was 10 percentage points or less. A 10 percentage-point noninferiority margin was considered to be an acceptable difference in recurrence rate.
Recruitment:
Investigators will include physicians in the emergency room and admission setting to help identify and recruit participants.
Methods: Data Collection, management and analysis
Enrollment:
First assessment including baseline variables and suitability of the participant to the study will be made during the enrollment, by the study coordinators.
In addition demographic and clinical characteristics will be recorded. The data will be collected during an interview of the participant or with assistance of the computerized medical records.
Furthermore, laboratory tests such as blood count, liver and kidneys functions and C reactive protein will be made and be recorded for each participant.
Interventions:
The type of intervention will be recorded by the study coordinators for each participant according to the allocation group.
Assessments of outcomes:
The primary outcome at each follow up, both telephonically and on clinical follow up The secondary outcomes will be assessed telephonically and using the medical computerized systems.
Data management:
All data regarding the participant's hospitalization: Baselines variables, interventions and glucose levels will be stored in secured excel documents for each study group.
Data regarding the participant's outcomes will be stored in a different secured excel documents for each study group.
The coding of the documents and the separation between the hospitalization and follow up period data is designated to ensure the investigator blinding.
Statistical analysis:
The primary outcome is the occurrence of Recurrent Pericarditis within 12 months. This will be calculated by bivariate analysis as relative risk. The secondary outcome of time to recurrence will be plotted using Kaplan-Meier curves and compared using the Log-rank test (unadjusted analysis), Hazard ratio for the risk of the primary analysis between the control and Dexamethasone arm will be calculated using a univariate cox proportional hazards ratio model (unadjusted analysis). Further secondary outcomes will be analysed by bivariate analysis.
Methods: monitoring Harms: Side effects will be monitoring during therapy as defined
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, non-blinded trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Therapy | Active comparator | Drug: NSAID therapyIbuprofen 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 |
| Dexamethasone therapy | Experimental | Drug: Dexamethasone therapyDexamethasone 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone therapyDexamethasone 20MG once daily for 4 days with additional colchicine therapy for 3 months | Drug | Dexamethasone therapy |
| NSAID therapyNSAIDS (Ibuprofen or Aspirin) or Glucocorticoid (Prednisone) therapy for 3 weeks with addional colchicine therapy for 3 months | Drug | Conventional Therapy |
Primary outcome
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.
6 secondary outcomes
The time to first recurrence
Time frame: 12 months
Disease-related re-hospitalization
Time frame: 12 months
Occurrence of new onset Atrial Fibrillation
Time frame: 12 months
Cardiac Tamponade
Time frame: 1 month
Constrictive Pericarditis
Time frame: 12 months
Side effects during therapy
Time frame: During therapy (4 days or 3 weeks depending on arm of therapy)
Results and safety
The study was stopped early (reason given: Difficulty in enrollment of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nili Schamroth Pravda, MbbCH study chair
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone therapy and NSAID therapy in people with Pericarditis Acute, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in enrollment of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Recurrent Pericarditis within 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.