A Phase 3 interventional study of Ivabradine 5mg Tab and Placebo Oral Tablet in Cardiogenic Shock Post Myocardial Infarction, sponsored by National Institute of Cardiovascular Diseases, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by National Institute of Cardiovascular Diseases, Pakistan · Phase 3, Interventional, and Treatment
Brief Summary:
The IVASHOCK trial investigates whether ivabradine can achieve at least one-class improvement in SCAI cardiogenic shock classification compared to placebo, and evaluates its safety profile in patients with cardiogenic shock (CS).
Primary Objectives:
Safety Endpoints:
Adverse events monitored include: sinus node dysfunction, new-onset atrial fibrillation or atrial flutter, atrioventricular block, drug-related hypotension, and ventricular arrhythmia.
Participant Schedule:
Participants will receive ivabradine or placebo orally every 12 hours for 3 days.
Hemodynamic and metabolic assessments will include:
Arterial pH, central venous oxygen saturation (ScvO2), and serum lactate - every 6 hours on Day 1, then every 8 hours on Days 2 and 3 Heart rate, mean arterial pressure (MAP), vasoactive/inotropic support dose, and urine output - measured on the same timeline
Signs of Hypoperfusion including:
Mixed venous oxygen saturation ≤ 65%
Exclusion Criteria:
Participants will receive standard treatment for STEMI complicated by cardiogenic shock, including revascularization, guideline-directed medical therapy as clinically appropriate, standardized vasopressor and inotropic support, and mechanical circulatory support when indicated. Participants will receive ivabradine 5 mg orally twice daily for up to 3 days, with a maximum of six doses. Study treatment will be discontinued if the heart rate decreases to \<72 bpm or a beta-blocker is initiated.
Drug: Ivabradine 5mg Tab
Participants will receive the same standard treatment for STEMI complicated by cardiogenic shock, including revascularization, guideline-directed medical therapy as clinically appropriate, standardized vasopressor and inotropic support, and mechanical circulatory support when indicated. Participants will receive a matching placebo tablet orally twice daily for up to 3 days, with a maximum of six doses. Study treatment will be discontinued if the heart rate decreases to \<72 bpm or a beta-blocker is initiated.
Drug: Placebo Oral Tablet
Ivabradine 5mg oral BID for 3 days (6 tablets)
Placebo tablets, with same color and texture, for 3 days in BID doses
Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio
The primary outcome will be analyzed using a hierarchical win ratio. Participants will be compared sequentially as follows: (1) greater increase in total shock score from baseline to 72 hours; the score ranges from 0 to 12 and sums four 0-3 components: mean arterial pressure/vasoactive support, mixed venous oxygen saturation, urine output, and arterial lactate, with higher scores indicating better status; (2) less vasoactive/inotropic support at 72 hours, and if the number of agents is equal, the lower total dose; (3) lactate \<2 mmol/L; (4) mixed venous oxygen saturation ≥65%; (5) urine output ≥30 mL/hour; and (6) heart rate \<100 beats/min without symptomatic bradycardia, high-grade atrioventricular block, or new atrial fibrillation/flutter. If participants remain equal after all components, the comparison will be a tie. The effect will be reported as the win ratio (ivabradine wins/placebo wins).
Time frame: 72 hours
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National Institute of Cardiovascular Diseases, Pakistan