CTRI/2010/091/000201已完成2 期
A Prospective, Randomized (3:1), Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ischemix LLC
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- To assess the safety
研究概览
简要总结
This study is a prospective, multi-center, blinded, randomized, placebo-controlled study, evaluating single-dose regimens of CMX-2043 (three doses) solution for IV administration or placebo (single dose) in subjects with stable coronary artery disease undergoing elective placement of stent by Percutaneous Coronary Intervention (PCI). Approximately 30 subjects will be randomized to each study group: low dose (0.8 mg/kg), medium dose (1.6 mg/kg), high dose (2.4 mg/kg) or placebo (0.24 mL/kg). The study aims to have a minimum of 120 evaluable subjects, defined as those subjects who have received the study medication dose and complete 24 hours after the last balloon inflation. The IV route of administration has been chosen as the appropriate method of delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects of 18 to 70 years of age (both inclusive).
- •Subjects with stable coronary artery disease, documented by coronary angiography within 28 days of PCI procedure.
- •Subjects who have stable coronary artery disease undergoing elective PCI (planned placement of a single stent of ≥ 18 mm or multiple stents).
- •Female subjects: a.
- •Surgically sterile with documented bilateral tubal ligation or hysterectomy OR b.
- •documented to be post-menopausal for at least one year OR c.
- •if of child-bearing potential, practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.
- •Subjects with CK-MB and troponin-T levels lower than the upper limit of normal as determined at local site laboratory.
- •Subjects free of acute injuries or illnesses that in the opinion of the investigator could increase the risk of the study to the subject or obscure the interpretation of results.
- •Subjects willing to undergo pre-and post-study physical exams and laboratory investigations.
- •Subjects willing to provide signed written informed consent form.
排除标准
- •Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
- •Subjects who had had an MI within 14 days prior to the PCI procedure.
- •Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
- •Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
- •Subjects with plasma creatinine level ≥ 1.5 times the upper limit of normal.
- •Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
- •Subjects with a history of alcohol or drug abuse.
- •Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- •Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
- •Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results.
- •Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.
- •A known history of drug hypersensitivity to CMX-2043 or any of the excipients of CMX-
- •Any other medical condition or reason that, in the Investigator's opinion, makes the subject unsuitable to participate in this clinical trial.
结局指标
主要结局
To assess the safety
时间窗: Measuring the changes in CK-MB values up to 24 hours after the last balloon inflation
次要结局
- To evaluate reduction of myocardial injury associated with stent PCI(Determined by serial measurements of cardiac biomarkers.)
研究者
研究点 (3)
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