Overview

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

Status:
Unknown status
Trial end date:
2020-07-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alberta
Treatments:
Acetylcysteine
N-monoacetylcystine
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