Arterial Occlusive DiseasesPhase 2TRIP-PCINCT02561000
Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
A Phase 2 study testing PZ-128 in people with Arterial Occlusive Diseases and Coronary Artery Disease, run by Tufts Medical Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusive Diseases, Coronary Artery Disease, Coronary Disease
- What is being tested?
- PZ-128
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 May 2016to 17 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is at least 18 years of age and may be of either sex/gender and of any race and ethnicity.
- The subject is scheduled to undergo non-emergent PCI or non-emergent cardiac catheterization with the intention of performing PCI. The following classifications of the urgency of the procedure at the time the operator decides to perform it will be used for randomization stratification:
- Elective: The cardiac catheterization procedure ± PCI can be performed on an outpatient basis or during a subsequent hospitalization without significant risk of MI or death. For stable inpatients, this is a procedure that is performed during the hospitalization for convenience and ease of scheduling only and not because the subject's clinical situation demands that the procedure be performed prior to discharge.
- OR
- Urgent: The cardiac catheterization ± PCI procedure should be performed on an inpatient basis and before discharge because of significant concerns about the risk of myocardial ischemia, MI and/or death. For subjects who are outpatients or in the emergency department at the time that the cardiac catheterization is requested, this is a procedure that would warrant hospital admission based on clinical presentation.
- There is no anticipation that the subject would require treatment with a GP IIb/IIIa inhibitor prior to the initiation of the cardiac catheterization ± PCI procedure if the subject were not a participant in the current research study, and no anticipation of use during the procedure.
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- The subject is willing and able to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and visit schedules (i.e., subject signs an approved informed consent document(s) and provides HIPAA authorization);
- The subject will undergo all of the pre-enrollment parameters according to the study protocol prior to randomization and have them completed within 14 days prior to the scheduled cardiac catheterization ± PCI procedure and study drug administration.
- Women of childbearing potential (all postmenarchal women who are <1 year menopausal or who have not had surgical sterilization or a hysterectomy are considered to be women of child-bearing potential) must agree to use a medically accepted method of contraception from the time written informed consent is given up until 90 days following the study drug administration.
- Subject Exclusion Criteria:
- The subject will be excluded from entry if any of the criteria listed below are met:
- (General Exclusions)
- Subject is pregnant, intends to become pregnant or is breast-feeding (all women of child-bearing potential must have a negative pregnancy test result confirmed prior to randomization and it must be repeated to be within 24 hours prior to the study drug administration if necessary).
- Any of the following allergy history(s):
- History of an allergic reaction* or contraindication to any of the following protocol-directed drugs: aspirin, heparin, P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor), antihistamines (benadryl, famotidine); or
- History of an allergic reaction* to contrast media; or
- History of an allergic reaction* to a drug which required emergency medical treatment;
- History of an allergic reaction* to a Hymenoptera sting which currently necessitates the subject to carry an EpiPen/injector or the subject has been prescribed one to treat an allergic reaction to a sting.
- An allergic (anaphylactic) reaction is characterized by an adverse local or general response from exposure to an allergen involving skin/mucosal tissue manifestations (hives, pruritus, flushing, angioedema), and/or respiratory compromise (dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia), and/or hemodynamic effects (hypo/hypertension, hypotonia, syncope).
- Participation in another research study of investigational therapy (drug or device) within the past 30 days prior to randomization or planned use of other investigational therapy(s) during this research study (until 90 days following the study drug administration).
- Subject is part of the study staff personnel directly involved with this trial, or is a family member of the study staff (clinical site or sponsor).
- Prior enrollment (randomization) in this research study.
- Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the research study or which would, in the opinion of the investigator, unacceptably increase the subject's risk by participating in the research study. This would include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy or any unexplained blackouts.
- (Exclusionary Prior/Concomitant Conditions)
- Evidence of an ST-segment elevation myocardial infarction (STEMI) on presentation or during current hospitalization or a history of STEMI within the past 30 days prior to randomization.
- Subject is scheduled to undergo PCI for known unprotected left main coronary artery (LMCA) disease (i.e., left main stenosis ≥50% not protected by at least 1 patent bypass graft).
- Any history of a prior stroke (hemorrhagic or ischemic) or transient ischemic attack (TIA) of any etiology.
- Cardiogenic or any type of shock on presentation or during current hospitalization (i.e., systolic blood pressure <90 mm Hg requiring vasopressor or hemodynamic support).
- History of heparin-induced thrombocytopenia (HIT).
- Any active bleeding within the past 30 days prior to randomization.
- Any condition or personal belief (e.g., Jehovah's Witness) which would interfere with the subject's ability or willingness to undergo a blood transfusion.
- Any of the following conditions associated with increased risk of bleeding:
- history of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra- articular bleeding;
- gastrointestinal bleeding within the past 30 days prior to randomization;
- gastric or duodenal ulcer disease verified by endoscopy or barium meal contrast technique within the past 6 months prior to randomization;
- history of bleeding disorder or diathesis;
- major surgical procedure or trauma within the past 60 days prior to randomization or a planned surgical procedure to take place within 30 days following the study drug administration;
- history or suspicion of intracranial neoplasm, arteriovenous malformation, or aneurysm; or
- clinical finding(s) in the judgment of the investigator that poses an increased risk of bleeding.
- Sustained severe hypertension: systolic blood pressure >185 mm Hg or diastolic blood pressure >105 mm Hg with or without anti-hypertensive treatment (as demonstrated by repeated BP measurements >185/105 mm Hg including the final BP measurement before randomization).
- Hypotension: systolic blood pressure <95 mm Hg (as demonstrated by repeated systolic BP measurements <95 mm Hg including the final systolic BP measurement prior to randomization).
- Known active hepatobiliary disease, or known unexplained persistent increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity to ≥2.5 times the upper limit of the reference range within the past 30 days prior to randomization.
- Hemoglobin <10 g/dL or hematocrit <30%.
- Platelet count <75,000/mm3.
- Stage 4-5 Chronic Kidney Disease (National Kidney Foundation) or on dialysis.
- Active sepsis or suspected sepsis.
- Body weight <60 kg or >175 kg.
- Current evidence of invasive cancer (persistent disease excluding basal cell carcinoma of the skin) or treatment for invasive cancer within the past 6 months prior to randomization.
- Left ventricular ejection fraction <25% if known (any imaging technique) or New York Heart Association (NYHA) Class IV congestive heart failure.
- (Exclusionary Prior/Concomitant/Anticipated Medication/Therapy)
- Coronary interventional procedure of any kind within the past 30 days prior to randomization.
- Anticipated subsequent staged multi-vessel PCI within 30 days following the study drug administration.
- History of treatment with any parenteral GP IIb/IIIa inhibitor (GPI) within the past 30 days prior to randomization. (As stated in the Inclusion section, the planned treatment with a GPI prior to initiation of the cardiac catheterization ± PCI is not allowed; however, GPI for thrombotic bailout may be used during the PCI at the investigator's discretion).
- Concurrent or anticipated treatment with a parenteral direct thrombin inhibitor (e.g., bivalirudin) for the cardiac catheterization ± PCI procedure.
- History of treatment with another PAR1 inhibitor within the past 60 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.
- History of treatment with another IV anti-platelet drug within 30 days prior to randomization or the concurrent/anticipated use after randomization up until 30 days following the study drug administration.
- Any of the following anticoagulant or thrombolytic/fibrinolytic treatment(s):
- History of treatment with warfarin within 5 days prior to randomization or the concurrent/anticipated use after randomization up until 2 days following the study drug administration; or
- History of treatment with oral Factor Xa or direct thrombin inhibitors within 2 days prior to randomization or the concurrent/anticipated use after randomization up until 2 days following the study drug administration; or
- History of treatment with thrombolytic/fibrinolytic agents within 7 days prior to randomization or the concurrent/anticipated use of any of those agents after randomization up until 30 days following the study drug administration.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Inova Heart and Vascular Institute, Inova Fairfax Hospital
Falls Church, Virginia, 22042
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention- Thrombin Receptor Inhibitory Pepducin in PCI (TRIP-PCI)
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.
- Conditions
- Arterial Occlusive Diseases, Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Heart Diseases, Myocardial Ischemia
- Being tested
- PZ-128, Placebo
- Keywords
- Platelets, Platelet Aggregation Inhibitors, Protease-Activated Receptor 1, Hemorrhage
- Medical subject headings
- Arterial Occlusive Diseases, Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Heart Diseases, Myocardial Ischemia, Vascular Diseases, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PZ-128Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PZ-128 0.3 mg/kg | Experimental | PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Receives: Drug: PZ-128 |
| PZ-128 0.5 mg/kg | Experimental | PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Receives: Drug: PZ-128 |
| Placebo | Placebo comparator | Placebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Occurrence of Major Plus Minor Thrombolysis in Myocardial Infarction (TIMI) Bleeding Events; Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Primary Safety)
All suspected bleeding events positively adjudicated by CEC in a blinded fashion, were used in the reporting of the number/percentage of observed participants with a first occurrence of a TIMI major or minor bleeding event.
Measured: From initiation of study drug up to 30 days following study drug
Secondary outcomes (2)
First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy)
All suspected MACE events positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the reporting of the number/percentage of observed participants with a first occurrence of the composite cardiovascular (CV) outcome measure comprised of CV death, non-fatal Myocardial Infarction (MI), non-fatal stroke (ischemic, hemorrhagic or unknown), recurrent ischemia requiring hospitalization, or urgent coronary revascularization. The number/percentage of observed participants with outcome measure events during the study were reported.
Measured: From randomization up to 30 days following study drug
First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy)
All suspected MACE events positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the reporting of the number/percentage of observed participants with a first occurrence of the composite cardiovascular (CV) outcome measure comprised of CV death, non-fatal Myocardial Infarction (MI), non-fatal stroke (ischemic, hemorrhagic or unknown), recurrent ischemia requiring hospitalization, or urgent coronary revascularization.
Measured: From randomization up to 90 days following study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start27 May 2016
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), RTI International, Inova Fairfax Hospital, University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Athan Kuliopulos, MD, PhD, Study director, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561000
- Sponsor's protocol ID
- TMC-PZ128-02
- Other IDs
- P50HL110789
- Acronym
- TRIP-PCI
- Status last verified
- Feb 2021
- First submitted
- 24 Sep 2015
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gurbel PA, Bliden KP, Turner SE, Tantry US, Gesheff MG, Barr TP, Covic L, Kuliopulos A. Cell-Penetrating Pepducin Therapy Targeting PAR1 in Subjects With Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2016 Jan;36(1):189-97. doi: 10.1161/ATVBAHA.115.306777.
PubMed 26681756Rana R, Huang T, Koukos G, Fletcher EK, Turner SE, Shearer A, Gurbel PA, Rade JJ, Kimmelstiel CD, Bliden KP, Covic L, Kuliopulos A. Noncanonical Matrix Metalloprotease 1-Protease-Activated Receptor 1 Signaling Drives Progression of Atherosclerosis. Arterioscler Thromb Vasc Biol. 2018 Jun;38(6):1368-1380. doi: 10.1161/ATVBAHA.118.310967. Epub 2018 Apr 5.
PubMed 29622563Kuliopulos A, Gurbel PA, Rade JJ, Kimmelstiel CD, Turner SE, Bliden KP, Fletcher EK, Cox DH, Covic L; TRIP-PCI Investigators. 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. Arterioscler Thromb Vasc Biol. 2020 Dec;40(12):2990-3003. doi: 10.1161/ATVBAHA.120.315168. Epub 2020 Oct 8.
PubMed 33028101Fletcher EK, Wang Y, Flynn LK, Turner SE, Rade JJ, Kimmelstiel CD, Gurbel PA, Bliden KP, Covic L, Kuliopulos A. Deficiency of MMP1a (Matrix Metalloprotease 1a) Collagenase Suppresses Development of Atherosclerosis in Mice: Translational Implications for Human Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2021 May 5;41(5):e265-e279. doi: 10.1161/ATVBAHA.120.315837. Epub 2021 Mar 25.
PubMed 33761760
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention- Thrombin Receptor Inhibitory Pepducin in PCI (TRIP-PCI)
- ClinicalTrials.gov ID
- NCT02561000
- Acronym / sponsor ID
- TRIP-PCI / TMC-PZ128-02
- Conditions
- Arterial Occlusive Diseases, Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Heart Diseases, Myocardial Ischemia
- Keywords
- Platelets, Platelet Aggregation Inhibitors, Protease-Activated Receptor 1, Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), RTI International, Inova Fairfax Hospital, University of Massachusetts, Worcester
- Study start
- 27 May 2016 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PZ-128 0.3 mg/kg | Experimental | Drug: PZ-128PZ-128, 0.3 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion |
| PZ-128 0.5 mg/kg | Experimental | Drug: PZ-128PZ-128, 0.5 mg/kg, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, in 250 cc 5% dextrose, single dose, 2-hour intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (60 listed)
- The subject is at least 18 years of age and may be of either sex/gender and of any race and ethnicity.
- The subject is scheduled to undergo non-emergent PCI or non-emergent cardiac catheterization with the intention of performing PCI. The following classifications of the urgency of the procedure at the time the operator decides to perform it will be used for randomization stratification:
- OR
- There is no anticipation that the subject would require treatment with a GP IIb/IIIa inhibitor prior to the initiation of the cardiac catheterization ± PCI procedure if the subject were not a participant in the current research study, and no anticipation of use during the procedure.
- The subject is willing and able to give appropriate informed consent and complete all study-related procedures, and able to adhere to dosing and visit schedules (i.e., subject signs an approved informed consent document(s) and provides HIPAA authorization);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PZ-128 | Drug | PZ-128 0.3 mg/kg, PZ-128 0.5 mg/kg |
| Placebo | Drug | Placebo |
Primary outcome
First Occurrence of Major Plus Minor Thrombolysis in Myocardial Infarction (TIMI) Bleeding Events; Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Primary Safety)
Time frame: From initiation of study drug up to 30 days following study drug
All suspected bleeding events positively adjudicated by CEC in a blinded fashion, were used in the reporting of the number/percentage of observed participants with a first occurrence of a TIMI major or minor bleeding event.
2 secondary outcomes
First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy)
Time frame: From randomization up to 30 days following study drug
First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy)
Time frame: From randomization up to 90 days following study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26681756Gurbel PA, Bliden KP, Turner SE, Tantry US, Gesheff MG, Barr TP, Covic L, Kuliopulos A. Cell-Penetrating Pepducin Therapy Targeting PAR1 in Subjects With Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2016 Jan;36(1):189-97. doi: 10.1161/ATVBAHA.115.306777.
- Results publication: PubMed 29622563Rana R, Huang T, Koukos G, Fletcher EK, Turner SE, Shearer A, Gurbel PA, Rade JJ, Kimmelstiel CD, Bliden KP, Covic L, Kuliopulos A. Noncanonical Matrix Metalloprotease 1-Protease-Activated Receptor 1 Signaling Drives Progression of Atherosclerosis. Arterioscler Thromb Vasc Biol. 2018 Jun;38(6):1368-1380. doi: 10.1161/ATVBAHA.118.310967. Epub 2018 Apr 5.
- Results publication: PubMed 33028101Kuliopulos A, Gurbel PA, Rade JJ, Kimmelstiel CD, Turner SE, Bliden KP, Fletcher EK, Cox DH, Covic L; TRIP-PCI Investigators. 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. Arterioscler Thromb Vasc Biol. 2020 Dec;40(12):2990-3003. doi: 10.1161/ATVBAHA.120.315168. Epub 2020 Oct 8.
- Derived from this study: PubMed 33761760Fletcher EK, Wang Y, Flynn LK, Turner SE, Rade JJ, Kimmelstiel CD, Gurbel PA, Bliden KP, Covic L, Kuliopulos A. Deficiency of MMP1a (Matrix Metalloprotease 1a) Collagenase Suppresses Development of Atherosclerosis in Mice: Translational Implications for Human Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2021 May 5;41(5):e265-e279. doi: 10.1161/ATVBAHA.120.315837. Epub 2021 Mar 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athan Kuliopulos, MD, PhD study director
Tufts Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PZ-128 in people with Arterial Occlusive Diseases and Coronary Artery Disease, run by Tufts Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 60 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Occurrence of Major Plus Minor Thrombolysis in Myocardial Infarction (TIMI) Bleeding Events; Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Primary Safety) (time frame: From initiation of study drug up to 30 days following study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02561000, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.