Cardiogenic Shock Post Myocardial InfarctionPhase 3IVASHOCKNCT07714746
Ivabradine in the Acute Management of Cardiogenic Shock
A Phase 3 study testing Ivabradine 5mg Tab in people with Cardiogenic Shock Post Myocardial Infarction, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiogenic Shock Post Myocardial Infarction
- What is being tested?
- Ivabradine 5mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Apr 2026to 31 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <90 OR MAP <60 OR >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)
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- 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, Requiring BiPAP or mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
National institute of cardiovascular diseases
Karachi
About this study
Official title: Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial
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).
Read more
Primary Objectives:
- To determine whether ivabradine improves SCAI shock classification by at least one class from baseline within 72 hours compared to placebo
- To assess whether ivabradine facilitates earlier weaning from vasoactive and inotropic support compared to placebo
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
- Being tested
- Ivabradine 5mg Tab, Placebo Oral Tablet
- Keywords
- ivabradine, cardiogenic shock, SCAI Shock Stage Classification, Heart Rate Reduction, Randomized clinical trial, Shock Severity Improvement
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivabradine 5mg TabDrug
Ivabradine 5mg oral BID for 3 days (6 tablets)
Placebo Oral TabletDrug
Placebo tablets, with same color and texture, for 3 days in BID doses
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine Plus Standard Care | Experimental | 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. Receives: Drug: Ivabradine 5mg Tab |
| Matching Placebo Plus Standard Care | Placebo comparator | 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. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start20 Apr 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic Shock Post Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Asim Ali, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Asim Ali, MBBS, Principal investigator, National Institute of Cardiovascular DiseasesAbdul Hakeem, MD FACC, FSCAI, FASE, Study chair, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714746
- Sponsor's protocol ID
- IRB-33/25
- Acronym
- IVASHOCK
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivabradine in the Acute Management of Cardiogenic Shock - IVASHOCK-a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07714746
- Acronym / sponsor ID
- IVASHOCK / IRB-33/25
- Keywords
- ivabradine, cardiogenic shock, SCAI Shock Stage Classification, Heart Rate Reduction, Randomized clinical trial, Shock Severity Improvement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine whether ivabradine improves SCAI shock classification by at least one class from baseline within 72 hours compared to placebo
- To assess whether ivabradine facilitates earlier weaning from vasoactive and inotropic support compared to placebo
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine Plus Standard Care | Experimental | Drug: Ivabradine 5mg TabParticipants 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. |
| Matching Placebo Plus Standard Care | Placebo comparator | Drug: Placebo Oral TabletParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18-75 years diagnosed with STEMI complicated by cardiogenic shock (CS) as defined by SCAI shock classification > C:
- SBP <90 OR MAP <60 OR >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)
Key exclusion criteria (7 listed)
- Age > 75 years
- CPR > 12 mints
- Atrial fibrillation
- Complete Heart Block
- Heart rate of < 100 bpm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivabradine 5mg TabIvabradine 5mg oral BID for 3 days (6 tablets) | Drug | Ivabradine Plus Standard Care |
| Placebo Oral TabletPlacebo tablets, with same color and texture, for 3 days in BID doses | Drug | Matching Placebo Plus Standard Care |
Primary outcome
Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio
Time frame: 72 hours
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asim Ali, MBBS principal investigator
National Institute of Cardiovascular Diseases
Abdul Hakeem, MD FACC, FSCAI, FASE study chair
National Institute of Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivabradine 5mg Tab in people with Cardiogenic Shock Post Myocardial Infarction, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umair Saleem, MBBS (+923363937264, umairsaleem1002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite Clinical Recovery at 72 Hours Assessed Using the Win Ratio (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.