Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
International CTEPH Association
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)
