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

NCT ID: NCT04023266

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2022-01-01

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.

Conditions

STEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intravenous N-Acetylcysteine

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intravenous N-Acetylcysteine

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

Intervention Type: DRUG

Other Intervention Names

Generic

Eligibility Criteria

Inclusion Criteria

Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:

1. Patient age ≥ 18 years

2. Have received thrombolysis, with intend to pursue a pharmaco-invasive reperfusion strategy. Onset of chest pain to reperfusion time of < 3hrs.

3. STEMI involving anterior and/or inferior wall

4. An absence of baseline Q-waves on the initial ECG: The presence of Q waves defined at baseline using the Selvester QRS screening criteria

5. 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

Exclusion Criteria

1. Previous myocardial infarction

2. Known to have moderate to severe LV systolic dysfunction (LV EF< 45%)

3. Known allergy to thrombolytic therapy or NAC

4. Presence of left bundle branch block

5. Cardiogenic shock (defined as systolic blood pressure of < 90mm Hg, for at least 30 minutes, not responsive to fluid resuscitation)

6. Permanent pacemaker or cardioverter defibrillator implanted previously

7. Patients with contra-indications to thrombolytic therapy

8. Patients with loss of consciousness or confusion

9. Patients with known chronic kidney disease (GFR < 30ml/min/m2) or on dialysis

10. Current pregnancy

11. Planned therapy with primary PCI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Graham, MD. FRCPC

Role: STUDY_CHAIR

University of Alberta

Locations

University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00087545

Identifier Type: -

Identifier Source: org_study_id