NCT02561000: TRIP-PCI

Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention

Completed Phase 2 Results posted Last updated 16 April 2025

What this trial tests

Phase 2 trial testing PZ-128 in Arterial Occlusive Diseases in 100 participants. Completed in 17 September 2019.

Timeline

27 May 2016

Primary endpoint
17 September 2019

17 September 2019

Quick facts

Lead sponsor	Tufts Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	100
Start date	27 May 2016
Primary completion	17 September 2019
Estimated completion	17 September 2019
Sites	3 locations across United States

Drugs / interventions tested

• PZ-128 — full drug profile →
• Placebo

Conditions studied

• Arterial Occlusive Diseases — all drugs for Arterial Occlusive Diseases →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Coronary Disease — all drugs for Coronary Disease →
• Arteriosclerosis — all drugs for Arteriosclerosis →

Sponsor

Tufts Medical Center

Who can join

18 and older, any sex, with Arterial Occlusive Diseases or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The object of the study is to determine whether different doses of PZ-128, when added to standard medical care in persons undergoing cardiac catheterization/percutaneous coronary intervention, will increase the risk of bleeding.

A secondary objective is to determine whether patients treated with PZ-128 have fewer cardiac events such as heart attack, bypass surgery or stroke compared with those persons treated with the standard of care.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protease-activated receptors (PARs): mechanisms of action and potential therapeutic modulators in PAR-driven inflammatory diseases.
   Heuberger DM, Schuepbach RA. · · 2019 · cited 274× · PMID 30976204 · DOI 10.1186/s12959-019-0194-8
2. Targeting PAR1: Now What?
   Flaumenhaft R, De Ceunynck K. · · 2017 · cited 73× · PMID 28558960 · DOI 10.1016/j.tips.2017.05.001
3. Noncanonical Matrix Metalloprotease 1-Protease-Activated Receptor 1 Signaling Drives Progression of Atherosclerosis.
   Rana R, Huang T, Koukos G, Fletcher EK, et al · · 2018 · cited 42× · PMID 29622563 · DOI 10.1161/atvbaha.118.310967
4. Protease-Activated Receptor 1 as Therapeutic Target in Breast, Lung, and Ovarian Cancer: Pepducin Approach.
   Covic L, Kuliopulos A. · · 2018 · cited 38× · PMID 30065181 · DOI 10.3390/ijms19082237
5. The domino effect triggered by the tethered ligand of the protease activated receptors.
   Han X, Nieman MT. · · 2020 · cited 34× · PMID 32853981 · DOI 10.1016/j.thromres.2020.08.004
6. PAR1 (Protease-Activated Receptor 1) Pepducin Therapy Targeting Myocardial Necrosis in Coronary Artery Disease and Acute Coronary Syndrome Patients Undergoing Cardiac Catheterization: A Randomized, Placebo-Controlled, Phase 2 Study.
   Kuliopulos A, Gurbel PA, Rade JJ, Kimmelstiel CD, et al · · 2020 · cited 26× · PMID 33028101 · DOI 10.1161/atvbaha.120.315168
7. Exploring the Chemical Features and Biomedical Relevance of Cell-Penetrating Peptides.
   Moreno-Vargas LM, Prada-Gracia D. · · 2024 · cited 14× · PMID 39795918 · DOI 10.3390/ijms26010059
8. Deficiency of MMP1a (Matrix Metalloprotease 1a) Collagenase Suppresses Development of Atherosclerosis in Mice: Translational Implications for Human Coronary Artery Disease.
   Fletcher EK, Wang Y, Flynn LK, Turner SE, et al · · 2021 · cited 13× · PMID 33761760 · DOI 10.1161/atvbaha.120.315837