ST-Segment Elevation Myocardial InfractionPhase 2NCT01007461
IK-1001 (Sodium Sulfide (Na2S) for Injection) in Subjects With Acute ST-Segment Elevation Myocardial Infarction
A Phase 2 study testing Sodium Sulfide (Na2S) for Injection in people with ST-Segment Elevation Myocardial Infraction, run by Mallinckrodt.
Trial summary
Myocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing damage to at least some of the heart muscle… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST-Segment Elevation Myocardial Infraction
- What is being tested?
- Sodium Sulfide (Na2S) for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presentation to study hospital or institution with diagnosis of STEMI based on clinical and ECG findings (subject presented with ≥ 30 minutes of ischemic chest pain, within 12 hours of symptom onset, and has persistent ST-segment elevation of ≥ 2 mm ST-segment elevation in at least 2 contiguous leads in the ECG.
- Age between 18 and 80 years (inclusive)
- Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form
Who cannot join
- Prior MI (as determined by subject history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic, or valvular heart disease
- Cardiac arrest within the past 28 days
- Requirement for urgent cardiac surgery
- Previous CABG surgery or PCI
- Evidence of moderate or severe CHF (Killip Classes III and IV)
- Any bradyarrhythmia that is expected to require a pacemaker through Day 4 (range 3 to 5 days), thus preventing the MRI
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- Unable to undergo a MRI (including disallowed metallic implants, unable to tolerate gadolinium contrast media, morbid obesity, or severe claustrophobia)
- Subjects with past or current renal impairment requiring dialysis
- Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion or hemorrhagic stroke within 6 weeks prior to presentation
- Known or suspected aortic dissection
- Subjects who have received treatment for asthma within the past 12 months
- Prior history of pulmonary disease requiring chronic oxygen therapy
- Females of childbearing potential
- Body weight > 150 kg or Body Mass Index (BMI) > 40 kg/m2
- Medical problem likely to preclude completion of the study
- Use of investigational drugs or devices within 30 days prior to enrollment into the study
- Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
- Known food allergy to sulfite-containing foods and/or any drug allergies to drugs that contain sulfur
About this study
Official title: A Phase 2, Randomized. Double-Blind, Dose-Escalation, Dose-Expansion, Placebo-Controlled, Multi-Center Study of IK-1001 to Evaluate Safety, Pharmacokinetics , and Proof-of-Concept Efficacy in Subjects With Acute ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention
Myocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing damage to at least some of the heart muscle being supplied by that artery. In a STEMI, a blood clot completely blocks the coronary artery. This can result in damage to the heart muscle that is supplied by the affected artery. The purpose of the IK-1001 STEMI Study is to evaluate the safety and effectiveness of an investigational study drug (IK-1001). IK-1001 is being studied to determine if it is safe and if it can reduce the amount of damage caused to the heart from a STEMI. Potential subjects may be eligible if they have been diagnosed with a STEMI and undergo a primary percutaneous coronary intervention (PCI, a procedure where a blocked coronary artery is unblocked during a cardiac catheterization), as well as meet other entry criteria. Up to 446 men and women, aged 18-80, will participate in this study at about 50 medical sites around the world. Study participation will last for about six months. Subjects will receive the study drug through an intravenous catheter over three hours during their PCI procedure. Subjects will be monitored in the hospital for approximately three to four days after the PCI. There are three follow-up visits at one, three and six months after the PCI with the study investigator after discharge from the hospital.
Read the detailed description
This is a Phase 2, randomized, dose-escalation, dose-expansion, double-blind, placebo-controlled, multi-center study that will evaluate safety, PK, and POC efficacy in subjects with acute STEMI undergoing PCI.
The study will be conducted in two parts. Part 1 is the dose escalation portion of the study. A minimum of 24 evaluable subjects will be enrolled into Part 1 to receive either IK-1001 (n = 18) or placebo (n = 6). Each subject will receive a continuous infusion of study drug at one of three dose escalating levels of 0.5, 1.0, or 1.5 mg/kg/hr infusion for 3 hours. At each dose level, 8 subjects will be enrolled (6 will receive IK-1001 and 2 will receive placebo). Placebo will consist of commercially available normal saline (NS) [0.9% sodium chloride (NaCl)].
Treatment with study drug (either IK-1001 or placebo) will be initiated only after informed consent is obtained and STEMI diagnosis is made based on clinical and ECG findings. ECG criteria for STEMI diagnosis include:
- Subjects presenting with ≥ 30 minutes of ischemic chest pain but within 12 hours of symptom onset
- Subjects having persistent ST-segment elevation of ≥ 2 mm in at least 2 contiguous leads in ECG
All subjects who receive study drug and have a successful PCI (defined as subjects in whom Grade 3 reperfusion was achieved) will be followed up for safety and efficacy for up to 6 months post-PCI and study drug infusion. Study samples will be collected from all subjects over the first 4 days following PCI for determination of PK parameters of sulfide in blood and thiosulfate in plasma. In Part 1, subjects who do not undergo a PCI for any reason will have study drug discontinued, will be excluded from the efficacy assessments but will be followed up for safety for 7 days, and will be replaced with a new subject.
Part 2 of the study will be an expansion of the highest safe continuous infusion dose evaluated in Part 1. Part 2 aims to further evaluate safety and establish POC efficacy at this dosing level. Initially, up to 190 eligible subjects will be randomized to receive either IK-1001 or placebo at a 1:1 ratio. Two interim analyses (IAs) will be done after 64 and 128 subjects complete the MI size evaluation at Day 4 (range 3 to 5 days), respectively. If there is a safety concern at any dose level, then enrollment in Part 2 will restart at the next lower safe dosing level determined from Part 1. If there is only an adequate or no efficacy signal at any dose level, then enrollment in Part 2 may restart at either an increased dose level (e.g., 1.75 mg/kg/hr for 3 hours) or at a longer duration of infusion (1.5 mg/kg/hr for 6 hours). A decision to stop the trial for safety, efficacy, or futility will be assessed at each IA. No more than 446 subjects will be enrolled in Part 2 of the study.
- Being tested
- Sodium Sulfide (Na2S) for Injection, Placebo
- Keywords
- Acute Myocardial Infarction (AMI), STEMI, Acute ST-Segment Elevation Myocardial Infraction (STEMI)
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Sulfide (Na2S) for InjectionDrug
Also called IK-1001
IK-1001 is Na2S administered as an isotonic solution for intravenous (IV) injection or continuous infusion. IK-1001 will be administered as a 3-hour continuous IV infusion started > 5 minutes but < 20 minutes (approximately) prior to coronary artery reperfusion.
PlaceboDrug
0.9% Sodium Chloride (NaCl) will be administered in the same manner as the experimental drug.
| Study group | Role | What they receive |
|---|---|---|
| IK-1001 | Experimental | IK-1001 Sodium Sulfide (Na2S) for Injection Receives: Drug: Sodium Sulfide (Na2S) for Injection |
| Placebo | Placebo comparator | 0.9% Sodium Chloride (NaCl) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatine Kinase, Muscle and Brain (CK-MB) Troponin T
Measured: Days 1 through 4, end of treatment
Secondary outcomes (4)
12-Lead ECG
Measured: Study duration
Vital Signs
Measured: Study duration
Adverse Events
Measured: Study Duration
Cardiac magnetic resonance imaging (MRI)
Measured: Day 4, end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Company decision. Non-safety related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-Segment Elevation Myocardial InfractionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007461
- Sponsor's protocol ID
- IK-1001-AMI-201
- Status last verified
- May 2017
- First submitted
- 26 Oct 2009
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized. Double-Blind, Dose-Escalation, Dose-Expansion, Placebo-Controlled, Multi-Center Study of IK-1001 to Evaluate Safety, Pharmacokinetics , and Proof-of-Concept Efficacy in Subjects With Acute ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01007461
- Acronym / sponsor ID
- IK-1001-AMI-201
- Keywords
- Acute Myocardial Infarction (AMI), STEMI, Acute ST-Segment Elevation Myocardial Infraction (STEMI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision. Non-safety related
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 4 Nov 2009 (estimated)
- 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.
Myocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing damage to at least some of the heart muscle being supplied by that artery. In a STEMI, a blood clot completely blocks the coronary artery. This can result in damage to the heart muscle that is supplied by the affected artery. The purpose of the IK-1001 STEMI Study is to evaluate the safety and effectiveness of an investigational study drug (IK-1001). IK-1001 is being studied to determine if it is safe and if it can reduce the amount of damage caused to the heart from a STEMI. Potential subjects may be eligible if they have been diagnosed with a STEMI and undergo a primary percutaneous coronary intervention (PCI, a procedure where a blocked coronary artery is unblocked during a cardiac catheterization), as well as meet other entry criteria. Up to 446 men and women, aged 18-80, will participate in this study at about 50 medical sites around the world. Study participation will last for about six months. Subjects will receive the study drug through an intravenous catheter over three hours during their PCI procedure. Subjects will be monitored in the hospital for approximately three to four days after the PCI. There are three follow-up visits at one, three and six months after the PCI with the study investigator after discharge from the hospital.
Detailed description
This is a Phase 2, randomized, dose-escalation, dose-expansion, double-blind, placebo-controlled, multi-center study that will evaluate safety, PK, and POC efficacy in subjects with acute STEMI undergoing PCI.
The study will be conducted in two parts. Part 1 is the dose escalation portion of the study. A minimum of 24 evaluable subjects will be enrolled into Part 1 to receive either IK-1001 (n = 18) or placebo (n = 6). Each subject will receive a continuous infusion of study drug at one of three dose escalating levels of 0.5, 1.0, or 1.5 mg/kg/hr infusion for 3 hours. At each dose level, 8 subjects will be enrolled (6 will receive IK-1001 and 2 will receive placebo). Placebo will consist of commercially available normal saline (NS) [0.9% sodium chloride (NaCl)].
Treatment with study drug (either IK-1001 or placebo) will be initiated only after informed consent is obtained and STEMI diagnosis is made based on clinical and ECG findings. ECG criteria for STEMI diagnosis include:
- Subjects presenting with ≥ 30 minutes of ischemic chest pain but within 12 hours of symptom onset
- Subjects having persistent ST-segment elevation of ≥ 2 mm in at least 2 contiguous leads in ECG
All subjects who receive study drug and have a successful PCI (defined as subjects in whom Grade 3 reperfusion was achieved) will be followed up for safety and efficacy for up to 6 months post-PCI and study drug infusion. Study samples will be collected from all subjects over the first 4 days following PCI for determination of PK parameters of sulfide in blood and thiosulfate in plasma. In Part 1, subjects who do not undergo a PCI for any reason will have study drug discontinued, will be excluded from the efficacy assessments but will be followed up for safety for 7 days, and will be replaced with a new subject.
Part 2 of the study will be an expansion of the highest safe continuous infusion dose evaluated in Part 1. Part 2 aims to further evaluate safety and establish POC efficacy at this dosing level. Initially, up to 190 eligible subjects will be randomized to receive either IK-1001 or placebo at a 1:1 ratio. Two interim analyses (IAs) will be done after 64 and 128 subjects complete the MI size evaluation at Day 4 (range 3 to 5 days), respectively. If there is a safety concern at any dose level, then enrollment in Part 2 will restart at the next lower safe dosing level determined from Part 1. If there is only an adequate or no efficacy signal at any dose level, then enrollment in Part 2 may restart at either an increased dose level (e.g., 1.75 mg/kg/hr for 3 hours) or at a longer duration of infusion (1.5 mg/kg/hr for 6 hours). A decision to stop the trial for safety, efficacy, or futility will be assessed at each IA. No more than 446 subjects will be enrolled in Part 2 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IK-1001 | Experimental | Drug: Sodium Sulfide (Na2S) for InjectionIK-1001 Sodium Sulfide (Na2S) for Injection |
| Placebo | Placebo comparator | Drug: Placebo0.9% Sodium Chloride (NaCl) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presentation to study hospital or institution with diagnosis of STEMI based on clinical and ECG findings (subject presented with ≥ 30 minutes of ischemic chest pain, within 12 hours of symptom onset, and has persistent ST-segment elevation of ≥ 2 mm ST-segment elevation in at least 2 contiguous leads in the ECG.
- Age between 18 and 80 years (inclusive)
- Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form
Key exclusion criteria (18 listed)
- Prior MI (as determined by subject history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic, or valvular heart disease
- Cardiac arrest within the past 28 days
- Requirement for urgent cardiac surgery
- Previous CABG surgery or PCI
- Evidence of moderate or severe CHF (Killip Classes III and IV)
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 |
|---|---|---|
| Sodium Sulfide (Na2S) for InjectionAlso: IK-1001IK-1001 is Na2S administered as an isotonic solution for intravenous (IV) injection or continuous infusion. IK-1001 will be administered as a 3-hour continuous IV infusion started > 5 minutes but < 20 minutes (approximately) prior to coronary artery reperfusion. | Drug | IK-1001 |
| Placebo0.9% Sodium Chloride (NaCl) will be administered in the same manner as the experimental drug. | Drug | Placebo |
Primary outcome
Creatine Kinase, Muscle and Brain (CK-MB) Troponin T
Time frame: Days 1 through 4, end of treatment
4 secondary outcomes
12-Lead ECG
Time frame: Study duration
Vital Signs
Time frame: Study duration
Adverse Events
Time frame: Study Duration
Cardiac magnetic resonance imaging (MRI)
Time frame: Day 4, end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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ST Segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock Post Myocardial Infarction
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Sulfide (Na2S) for Injection in people with ST-Segment Elevation Myocardial Infraction, run by Mallinckrodt.
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 3 inclusion and 18 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: withdrawn, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatine Kinase, Muscle and Brain (CK-MB) Troponin T (time frame: Days 1 through 4, end of treatment). 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 19 May 2017.