NCT03273257终止2 期
A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Change From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA)
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.
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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a male or nonpregnant and nonlactating female patient aged from 18 to 80 years, both inclusive
- •Is diagnosed with operable CTEPH and anticipating symptomatic and/or prognostic benefit from PEA
- •Has pulmonary vascular resistance (PVR) >800 dyn·s·cm-5
- •Has undergone right heart catheterisation not more than 180 days before randomisation visit
- •Has been treated with anticoagulants for at least 90 days before randomisation visit
- •Has ability to swallow oral medication
- •Has ability and willingness to participate and access the health facility
- •Is capable of understanding the written informed consent and provides signed and witnessed written informed consent
- •Female patient must be either surgically sterile, postmenopausal (no menses for the previous 12 months), or must be practicing an effective method of birth control as determined by the investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or male partner with vasectomy or complete abstinence)
排除标准
- •Has unstable disease in need of urgent PEA surgery as determined by the treating physician
- •Has known hypersensitivity, allergic, or adverse reactions to riociguat or any of the excipients comprising riociguat tablets.
- •Has known active hepatitis A IgM (HAV-IgM), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab)
- •Is human immunodeficiency virus positive
- •Has pulmonary veno-occlusive disease
- •Has symptomatic hypotension
- •Has symptomatic carotid disease
- •Has significant coronary atherosclerotic disease in need of intervention
- •Has severe left heart disease in need of intervention
- •Has redo sternotomy
- •Has received any background therapy for pulmonary arterial hypertension (PAH) in the preceding 30 days before randomisation visit including endothelin receptor antagonists (ERAs), phosphodiesterase 5 (PDE5) inhibitors, or prostanoids
- •Is receiving nitrates, nitric oxide donors (e.g. amyl nitrite), ERAs, prostanoids, specific PDE5 inhibitors, nonspecific phosphodiesterase inhibitors (e.g. dipyridamole, theophylline)
- •Is receiving strong cytochrome P450 (CYP) and P-glycoprotein/breast cancer resistance protein inhibitors
- •Is receiving strong CYP3A inducers
- •Has creatinine clearance <15 mL/min or on any form of dialysis
- •Has severe hepatic impairment classified as Child-Pugh C
- •Has received an investigational drug within the past 4 weeks before randomisation visit
- •Is a lactating or pregnant (as demonstrated by a serum pregnancy test) woman, and not willing to take measures for not to become pregnant during the 3 months treatment study period and one month after the last dose of study drug administered
- •Has smoked or used tobacco in any form, including snuff or chewing within 3 months prior to randomisation visit
- •Has idiopathic interstitial pneumonitis
研究组 & 干预措施
Riociguat
Active Comparator
Patients will receive riociguat for 3 months followed by pulmonary endarterectomy.
干预措施: Riociguat (Drug)
Riociguat
Active Comparator
Patients will receive riociguat for 3 months followed by pulmonary endarterectomy.
干预措施: Pulmonary endarterectomy (Procedure)
Placebo
Placebo Comparator
Patients will receive placebo for 3 months followed by pulmonary endarterectomy.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Patients will receive placebo for 3 months followed by pulmonary endarterectomy.
干预措施: Pulmonary endarterectomy (Procedure)
结局指标
主要结局
Change From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA)
时间窗: 90 days
Pulmonary vascular resistance (PVR) will be assessed at baseline and immediately before pulmonary endarterectomy. The change in PVR will be assessed as percentage.
次要结局
- Number of Patients With Either All-cause Death, PH-related Hospitalization, Need for PAH-targeted Therapy or WHO Functional Class Unchanged or Worse Between Randomization and 6 Months Post Pulmonary Endarterectomy (Composite Endpoint)(270 days)
- Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane(intraoperative)
- Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance(intraoperative)
- Change From Baseline in Pulmonary Vascular Resistance (PVR) to 6 Months Post Pulmonary Endarterectomy (PEA)(270 days)
- Intraoperative Circulatory Arrest Time(intraoperative)
- Number of Patients With Intraoperative Surgery-related Complications (Composite Endpoint)(intraoperative)
- Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall(intraoperative)
- Number of Patients Who Died During the Course of the Study(270 days)
- Patients Who Withdraw During the Randomized Treatment Phase(90 days)
研究者
研究点 (4)
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