Condition or disease | Intervention/treatment | Phase |
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STEMI | Drug: Intravenous N-Acetylcysteine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Investigator-initiated prospective, single-center, double- arm non-blinded randomized controlled trial. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | The clinical outcomes assessor reading the cardiac MRI would be blinded to the study arm allotment. |
Primary Purpose: | Treatment |
Official Title: | A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in Patients Undergoing Pharmaco-invasive Reperfusion Early After an ST-segment Elevation Myocardial Infarction |
Actual Study Start Date : | September 20, 2019 |
Estimated Primary Completion Date : | July 31, 2020 |
Estimated Study Completion Date : | July 31, 2020 |
Arm | Intervention/treatment |
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Experimental: Intravenous N-Acetylcysteine arm
On arrival at the recruiting hospital, eligible and consenting STEMI patients randomly allocated to the experimental arm would be administered an intravenous N-Acetylcysteine bolus of 1200 mg over 0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5% dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours.
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Drug: Intravenous N-Acetylcysteine
Intravenous N-acetyl cysteine bolus and infusion as described in the experimental arm.
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No Intervention: Control arm
Patients randomized to this arm would receive no experimental therapies and would continue to receive all standard guideline recommended medical therapies and interventions.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:
Have a high-risk STEMI ECG defined as:
Exclusion Criteria:
Contact: Anoop Mathew, MD | 7807201927 ext 7804071590 | anoop2@ualberta.ca | |
Contact: Michelle Graham, MD, FRCPC | 7804071590 ext 2 | mmg2@ualberta.ca |
Canada, Alberta | |
University of Alberta Hospital | Recruiting |
Edmonton, Alberta, Canada, T6G 2B7 | |
Contact: Anoop Mathew, MD anoop2@ualberta.ca | |
Contact: Michelle Graham, MD mmg2@ualberta.ca | |
Sub-Investigator: Richard Coulden, MD, FRCPC | |
Sub-Investigator: Kevin Bainey, MD, FRCPC | |
Sub-Investigator: Evangelos Michelakis, MD | |
Sub-Investigator: Sean van Diepen, MD, FRCPC |
Study Chair: | Michelle Graham, MD. FRCPC | University of Alberta |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 9, 2019 | ||||||||
First Posted Date ICMJE | July 17, 2019 | ||||||||
Last Update Posted Date | September 25, 2019 | ||||||||
Actual Study Start Date ICMJE | September 20, 2019 | ||||||||
Estimated Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI | ||||||||
Official Title ICMJE | A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in Patients Undergoing Pharmaco-invasive Reperfusion Early After an ST-segment Elevation Myocardial Infarction | ||||||||
Brief Summary | The PANACEA trial is an investigator-initiated prospective, single-center, two-arm, non-blinded pilot randomized controlled trial of high-dose IV N-Acetylcysteine therapy used as an adjunct to pharmaco-invasive reperfusion in patients presenting early after a large STEMI. | ||||||||
Detailed Description | Patients presenting with ST-segment elevation myocardial infarction within 3 hours of symptom onset and satisfying all of the inclusion criteria after informed consent would be randomly allocated to either intravenous N-Acetylcysteine or standard treatment using a 1:1 allocation ratio. Those randomized to IV N-Acetylcysteine would be administered a bolus of 1200 mg over 0.5 hours (in 5% Dextrose) followed by 600mg/hour for the remaining 47.5 hours (in 5% dextrose). A total N-acetylcysteine dose of 29.7 grams is administered over 48 hours. The infusion is continued during the primary percutaneous coronary intervention. Patients would be followed up for a minimum of 90 days. The primary clinical endpoint will be myocardial infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first medical contact. Primary feasibility outcome will be the rate of recruitment, the number of patients undergoing cardiac MRI within the stipulated time frame, and completeness of the study data collection. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Investigator-initiated prospective, single-center, double- arm non-blinded randomized controlled trial. Masking: Single (Outcomes Assessor)Masking Description: The clinical outcomes assessor reading the cardiac MRI would be blinded to the study arm allotment. Primary Purpose: Treatment
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Condition ICMJE | STEMI | ||||||||
Intervention ICMJE | Drug: Intravenous N-Acetylcysteine
Intravenous N-acetyl cysteine bolus and infusion as described in the experimental arm.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
40 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 31, 2020 | ||||||||
Estimated Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04023266 | ||||||||
Other Study ID Numbers ICMJE | Pro00087545 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Alberta | ||||||||
Study Sponsor ICMJE | University of Alberta | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | University of Alberta | ||||||||
Verification Date | September 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |