Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients

TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH. The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment.

NCT Number	NCT06317805
Lead Sponsor	AOP Orphan Pharmaceuticals AG Collaborators: ANOVA CRO s.r.o., PharmaLex Belgium, Aixial s.r.o., GCP-Service International Ltd. & Co. KG
Conditions	Pulmonary Arterial Hypertension
Enrollment	110 participants
Start Date	2023-12-06
Primary Completion	2027-06 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-03-19