BridgeMD
New treatment option for Cardiogenic Shock Post Myocardial Infarction
Official title Ivabradine in the Acute Management of Cardiogenic Shock
ClinicalTrials.gov ID: NCT07714746
What this study is testing
What is Ivabradine 5mg Tab?
Ivabradine 5mg Tab is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cardiogenic shock post myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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: 1.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients aged 18-75 years diagnosed with STEMI complicated by cardiogenic shock (CS) as defined by SCAI shock classification \> C: Signs of...
- SBP \ 30 mmHg drop from baseline AND drugs/device used to maintain BP above these targets
- Cold, clammy extremities
- Urine output \<30 mL/h
- pulmonary congestion (either crackles, congestion in chest X-ray or B-lines in lung US)
You likely can't join if
- Age \> 75 years
- CPR \> 12 mints
- Atrial fibrillation
- Complete Heart Block
- Heart rate of \< 100 bpm
- End stage Renal Disease
See the full eligibility criteria
- Patients aged 18-75 years diagnosed with STEMI complicated by cardiogenic shock (CS) as defined by SCAI shock classification \> C: Signs of Hypoperfusion including:
- SBP \ 30 mmHg drop from baseline AND drugs/device used to maintain BP above these targets
- Cold, clammy extremities
- Urine output \<30 mL/h
- pulmonary congestion (either crackles, congestion in chest X-ray or B-lines in lung US)
- Mixed venous oxygen saturation ≤ 65%
- Severe Left ventricular (LV) dysfunction or right ventricular (RV) infarction
- Heart rate (HR) ≥ 100 bpm (Sinus Rhythm) in whom beta-blocker therapy cannot be initiated, including: On inotropic or vasopressor support, Requiring an intra-aortic balloon pump (IABP), With Killip class III or IV...
- Age \> 75 years
- CPR \> 12 mints
- Atrial fibrillation
- Complete Heart Block
- Heart rate of \< 100 bpm
- End stage Renal Disease
- Extensive comorbidities; Prior CVA, Malignancy, Pregnancy or Ongoing Participation in Other Trials
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.