IK-1001 (Sodium Sulfide (Na2S) for Injection) in Subjects With Acute ST-Segment Elevation Myocardial Infarction

NCT01007461 | Withdrawn Phase 2 DMC

• 1 other identifier: IK-1001-AMI-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

ST-Segment Elevation Myocardial Infraction

Keywords

Acute Myocardial Infarction (AMI); STEMI; Acute ST-Segment Elevation Myocardial Infraction (STEMI)

Outcome Measures

Primary Outcomes (1)

• Creatine Kinase, Muscle and Brain (CK-MB) Troponin T

  Days 1 through 4, end of treatment

Secondary Outcomes (4)

• 12-Lead ECG

  Study duration

• Vital Signs

  Study duration

• Adverse Events

  Study Duration

• Cardiac magnetic resonance imaging (MRI)

  Day 4, end of treatment

Study Arms (2)

IK-1001

EXPERIMENTAL

IK-1001 Sodium Sulfide (Na2S) for Injection

Drug: Sodium Sulfide (Na2S) for Injection

Placebo

PLACEBO COMPARATOR

0.9% Sodium Chloride (NaCl)

Drug: Placebo

Interventions

Sodium Sulfide (Na2S) for Injection DRUG

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.

Also known as: IK-1001

IK-1001

Placebo DRUG

0.9% Sodium Chloride (NaCl) will be administered in the same manner as the experimental drug.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mallinckrodt: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

sodium sulfide; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: November 4, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 19, 2017

Record last verified: 2017-05