IK-1001 (Sodium Sulfide (Na2S) for Injection) in Subjects With Acute ST-Segment Elevation Myocardial Infarction
Status:
Withdrawn
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.