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STEMIPhase 2PANACEANCT04023266

A Pilot Randomized Controlled Trial of Intravenous N-acetyl Cysteine in STEMI

A Phase 2 study testing Intravenous N-Acetylcysteine in people with STEMI, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
STEMI
What is being tested?
Intravenous N-Acetylcysteine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteCanada
Study dates
20 Sep 2019to 1 Jan 2022
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:
  • Patient age ≥ 18 years
  • Have received thrombolysis, with intend to pursue a pharmaco-invasive reperfusion strategy. Onset of chest pain to reperfusion time of < 3hrs.
  • STEMI involving anterior and/or inferior wall
  • An absence of baseline Q-waves on the initial ECG: The presence of Q waves defined at baseline using the Selvester QRS screening criteria
  • Have a high-risk STEMI ECG defined as:
  • ≥2mm ST-segment elevation in 2 anterior or lateral leads; or
  • ≥2 mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4 mm

Who cannot join

  • Previous myocardial infarction
  • Known to have moderate to severe LV systolic dysfunction (LV EF< 45%)
  • Known allergy to thrombolytic therapy or NAC
  • Presence of left bundle branch block
  • Cardiogenic shock (defined as systolic blood pressure of < 90mm Hg, for at least 30 minutes, not responsive to fluid resuscitation)
  • Permanent pacemaker or cardioverter defibrillator implanted previously
Show all 11Show fewer
  • Patients with contra-indications to thrombolytic therapy
  • Patients with loss of consciousness or confusion
  • Patients with known chronic kidney disease (GFR < 30ml/min/m2) or on dialysis
  • Current pregnancy
  • Planned therapy with primary PCI

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
STEMI
Being tested
Intravenous N-Acetylcysteine
Keywords
STEMI
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous N-AcetylcysteineDrug

    Also called Generic

    Intravenous N-acetyl cysteine bolus and infusion as described in the experimental arm.

Study groups in NCT04023266
Study groupRoleWhat they receive
Intravenous N-Acetylcysteine armExperimentalOn 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.
Receives: Drug: Intravenous N-Acetylcysteine
Control armNo interventionPatients randomized to this arm would receive no experimental therapies and would continue to receive all standard guideline recommended medical therapies and interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial infarct size

    The primary clinical endpoint will be myocardial infarct size measured by late gadolinium enhancement CMR imaging at 3-5 days from first medical contact.

    Measured: 3-5 days after first medical contact

  2. Feasibility outcomes

    Primary feasibility outcomes would include the rate of recruitment, the number of patients undergoing cardiac MRI within the stipulated time frame, and completeness of the study data collection.

    Measured: Assessed at the end of the study

Secondary outcomes (8)

  1. Myocardial salvage

    Myocardial salvage as measured by T2-weighted short tau inversion recovery on CMR assessed at 3-5 days after infarction

    Measured: 3-5 days after infarction

  2. Left ventricular ejection fraction

    Left ventricular ejection fraction on CMR at 3-5 days

    Measured: 3-5 days after infarction

  3. ST-segment elevation resolution

    ST-segment elevation resolution at 90 minutes after thrombolysis as assessed by the worst lead on electrocardiogram (ECG core lab).

    Measured: 90-minutes after thrombolysis

  4. TIMI frame count in infarct related artery

    TIMI frame count on baseline coronary angiogram in the infarct-related artery

    Measured: During index coronary angiogram which will be performed within 24 hours of admission

  5. Creatine kinase MB area under the curve

    Creatine kinase MB area under the curve through 24 hours

    Measured: 24 hours after admission

  6. Von Willebrand factor fragmentation

    The proportion of Von Willebrand factor multimers in the low, intermediate and high molecular weight form at the time of angiography

    Measured: At the time of angiography, assessed up to 7 days from admission

  7. Bleeding

    Bleeding research consortium type II, III and V bleeding; safety outcome

    Measured: From time of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days

  8. Allergic reactions

    Allergic reactions including hypotension (SBP< 90 mm Hg or a fall in BP >30 mm Hg below baseline), urticaria, flushing, wheezing and/or angioedema

    Measured: From time of randomization, upto 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2019
  2. Study start20 Sep 2019
  3. Primary completion15 Nov 2020
  4. Study completion1 Jan 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Investigator-initiated prospective, single-center, double- arm non-blinded randomized controlled trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023266
Sponsor's protocol ID
Pro00087545
Acronym
PANACEA
Status last verified
Jul 2022
First submitted
9 Jul 2019
Last updated
6 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data regarding IPD will be made available on reasonable request

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous N-Acetylcysteine in people with STEMI, run by University of Alberta at 1 site in Canada.

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 8 inclusion and 11 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: finished, as of the sponsor's last update on 6 Oct 2022. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Myocardial infarct size (time frame: 3-5 days after first medical contact). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04023266.

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 6 Oct 2022.

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