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A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

Study category: Heart and Blood Conditions

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Description

If you agree to join the study, screening tests will be performed while you are in the hospital to assess your eligibility for the study. If you are eligible to take part in the study, you will be randomized to receive either the study drug or placebo. ?Randomized? means that you will be assigned by chance, like flipping a coin, to take the study drug (CSL112) or the placebo. You will have a 50/50 chance of receiving either CSL112 or placebo. Both the study drug and placebo will be given by intravenous (IV) infusion which means slowly pumping the drug into your body through a small tube that is inserted into a vein. The infusion will last approximately 2 hours. You will receive up to four (4) infusions of either the study drug or placebo weekly for 4 weeks; each infusion is to be given at least 5 days apart. All 4 infusions should be administered within 30 days of you receiving your first infusion. Additional study visits will occur throughout the next year to assess for any new health problems, side effects, or changes in your medical conditions. This is a double-blind study, which means you, your Study Doctor, and the study staff will not know which treatment you are getting, but your Study Doctor can find out if there is an emergency, if it is critical to know for your health, or after the study has ended and the results have been analyzed. Your participation in the study will be approximately 1 year (365 days). This includes the Screening Period (1 visit), an Active Treatment Period (which includes 4 weekly infusion visits and a follow-up visit for safety) and a Follow-Up Period (which includes 5 visits) to assess any new health problems or side effects you may have experienced since your last study visit and your overall well-being. This study will have 11 study visits, 2 of which may be conducted by telephone during the Follow-Up period.

Details
Age

Adult

Eligibility

1. Capable of providing written informed consent and willing and able to adhere to all protocol requirements. 2. Male or female at least 18 years of age at the time of providing written informed consent. 3. Evidence of myocardial necrosis in a clinical setting consistent with type I (spontaneous) MI as defined by the following: a. Detection of a rise and / or fall in cardiac troponin I or T with at least 1 value above the 99th percentile upper reference limit. AND b. Any 1 or more of the following: i. Symptoms of ischemia (ie, resulting from a primary coronary artery event). ii. New (or presumably new) significant ST/T wave changes or left bundle branch block. iii. Development of pathological Q waves on electrocardiogram. iv. Imaging evidence of new loss of viable myocardium or regional wall motion abnormality. v. Identification of intracoronary thrombus by angiography. 4. No suspicion of acute kidney injury at least 12 hours after IV contrast agent administration (subjects who have undergone angiography) or after first medical contact for the index MI (subjects who have not undergone angiography). There must be documented evidence of stable renal function defined as no more than an increase in serum creatinine < 0.3 mg/dL (~27 &#956;mol/L) from pre-contrast serum creatinine value. 5. Evidence of multivessel coronary artery disease defined as meeting 1 or more of the following criteria: a. At least 50% stenosis on > 1 epicardial artery or left main artery on catheterization performed during the index hospitalization. b. Prior cardiac catheterization with at least 50% stenosis on > 1 epicardial artery or left main artery. c. Prior percutaneous coronary intervention and evidence of at least 50% stenosis of at least 1 epicardial artery different from prior revascularized artery. d. Prior multivessel coronary artery bypass grafting. 6. At least 1 of the following established risk factors: a. Age &#8805; 65 years. b. Prior history of MI. c. On pharmacological treatment for diabetes mellitus. d. Peripheral arterial disease.

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Location

Memorial Hospital Central

Principal Investigator
James Strader

James Strader

Study ID

Protocol Number: 18-6051

ClinicalTrials.gov: NCT03473223

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