NCT01167023已完成2 期
A Double-Blind, Randomized, Multicenter Study of Prasugrel Compared to Placebo in Adult Patients With Sickle Cell Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration
研究概览
简要总结
The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring medical intervention compared to placebo for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with Sickle Cell Disease (SCD).
- •Are greater than or equal to 50 kilograms (kg) at time of screening.
- •Are not currently being treated with an investigational drug (use of hydroxyurea, which is not an investigational drug, is permitted under this protocol if the patient has been on a stable dose for at least 30 days prior to randomization and has no signs of hematological toxicity at screening.
- •Agree to use a reliable method of birth control during the study or are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
排除标准
- •Acute painful crisis (requiring medical attention) within 30 days prior to screening.
- •Have a concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period (approximately 30 days).
- •Severe hepatic dysfunction (cirrhosis, portal hypertension, or aspartate aminotransferase (AST) greater than or equal to 3x upper limit of normal [ULN]).
- •Renal dysfunction requiring chronic dialysis.
- •Contraindication for antiplatelet therapy.
- •History of intolerance or allergy to approved thienopyridines.
- •Have signs or symptoms of an infection.
- •Hypertension (systolic blood pressure >180 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg) at the time of screening or randomization.
- •Hematocrit <18%.
- •Any history of bleeding diathesis, bleeding requiring in-hospital treatment, or papillary necrosis.
- •Active internal bleeding.
- •History of spontaneous gastrointestinal (GI) bleeding requiring in-hospital treatment.
- •Gross hematuria. Microhematuria, common in SCD patients, is not a contraindication.
- •Platelet count <100,000 per cubic millimeter.
- •Any history of intraocular hemorrhage.
- •Prior history of transient ischemic attack (TIA), ischemic stroke, hemorrhagic stroke, or other intracranial hemorrhage.
- •Known history of intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
- •Have an international normalized ratio (INR) of greater than 1.5 at screening.
- •Have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days.
- •History of menorrhagia requiring medical intervention.
研究组 & 干预措施
7.5 mg Prasugrel
Experimental
Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel.
干预措施: Prasugrel (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
5 mg Prasugrel
Experimental
干预措施: Prasugrel (Drug)
结局指标
主要结局
Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration
时间窗: Baseline through 30 days
A hemorrhagic event requiring medical intervention. Medical intervention was defined as any medical attention resulting in therapy or further investigation during the 30-day treatment duration.
次要结局
- Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment Duration(Baseline through 30 days)
- Percentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration(Baseline through 30 days)
- Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration(Baseline through 30 days)
- Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days(30 days)
- Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration(Baseline through 30 days)
- P2Y12 Reaction Units (PRU) as Measured by Accumetrics VerifyNow® P2Y12 (VN P2Y12) at 30 Days(30 days)
研究者
研究点 (1)
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