Trial · NCT02561000
Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
NCT02561000, Phase 2, Completed, Tufts Medical Center; results first posted 2021-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention. Trials, record NCT02561000. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02561000
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of PZ-128 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
- NCT number
- NCT02561000
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Arterial Occlusive Diseases, Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Heart Diseases, Myocardial Ischemia, Vascular Diseases, Acute Coronary Syndrome
- Interventions
- PZ-128, Placebo
- First posted
- 2015-09-25
- Last updated
- 2025-04-16
- Results first posted
- 2021-03-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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. |
| Secondary | First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | From randomization up to 30 days following study drug | 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. |
| Secondary | First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | From randomization up to 90 days following study drug | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | From initiation of study drug up to 30 days following study drug | The Safety population included randomized participants who received any amount of the study drug dose of the double-blind IP infusion (summarized and analyzed as treated). Four patients assigned to PZ-128 0.3 mg/kg did not receive randomized treatment allocation: 1 patient received placebo in error and was evaluated as placebo for primary safety outcome and adverse events; 2 patients withdrew consent right after randomization; and 1 patient had an adverse event prior to receiving any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | From randomization up to 30 days following study drug | The Intent-to-treat (ITT) population included all randomized participants, regardless of study drug intake, who underwent at least 1 follow-up assessment within 30 days after study drug dosing. Two patients (PZ-128 0.3 mg/kg) could not be evaluated for the 30-day outcome due to complete study withdrawal shortly after randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | From randomization up to 90 days following study drug | The Intent-to-treat (ITT) population included all randomized participants, regardless of study drug intake, who underwent at least 1 follow-up assessment after 30 days up until 90 days after study drug dosing. 5 patients could not be evaluated for the 90-day outcome: 1 placebo withdrew at 21 d; 2 PZ-128 0.3 mg/kg withdrew post randomization; 1 PZ-128 0.3 mg/kg withdrew at 7 d; and 1 PZ-128 0.3 mg/kg patient was followed only for 30 d ITT outcome (no study drug due to AE post randomization). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) | Placebo | 0 | Participants | ||
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) | PZ-128 0.3 mg/kg | 1 | Participants | ||
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) | PZ-128 0.5 mg/kg | 0 | Participants | ||
| First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | Placebo | 2 | Participants | ||
| First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | PZ-128 0.3 mg/kg | 0 | Participants | ||
| First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | PZ-128 0.5 mg/kg | 0 | Participants | ||
| First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | Placebo | 2 | Participants | ||
| First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | PZ-128 0.3 mg/kg | 0 | Participants | ||
| First Occurrence of Major Adverse Cardiovascular Event (MACE); Number/Percentage of Observed Participants With Outcome Measure Events During the Study (Secondary Efficacy) | PZ-128 0.5 mg/kg | 1 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 34 | |
| Overall Study | STARTED | PZ-128 0.3 mg/kg | 35 | |
| Overall Study | STARTED | PZ-128 0.5 mg/kg | 31 | |
| Overall Study | Safety Population | Placebo | 35 | |
| Overall Study | Safety Population | PZ-128 0.3 mg/kg | 31 | |
| Overall Study | Safety Population | PZ-128 0.5 mg/kg | 31 | |
| Overall Study | Intent-to-Treat (ITT) Population at 30 Days | Placebo | 34 | |
| Overall Study | Intent-to-Treat (ITT) Population at 30 Days | PZ-128 0.3 mg/kg | 33 | |
| Overall Study | Intent-to-Treat (ITT) Population at 30 Days | PZ-128 0.5 mg/kg | 31 | |
| Overall Study | Intent-to-Treat (ITT) Population at 90 Days | Placebo | 33 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial Fibrillation | Cardiac disorders | Placebo | 2 | 35 | 2 |
| other | Atrial Fibrillation | Cardiac disorders | PZ-128 0.3 mg/kg | 1 | 31 | 1 |
| other | Atrial Fibrillation | Cardiac disorders | PZ-128 0.5 mg/kg | 1 | 31 | 1 |
| other | Headache | Nervous system disorders | Placebo | 2 | 35 | 2 |
| other | Headache | Nervous system disorders | PZ-128 0.3 mg/kg | 1 | 31 | 1 |
| other | Headache | Nervous system disorders | PZ-128 0.5 mg/kg | 1 | 31 | 1 |
| other | Hypoesthesia | Nervous system disorders | Placebo | 2 | 35 | 2 |
| other | Hypoesthesia | Nervous system disorders | PZ-128 0.3 mg/kg | 0 | 31 | 0 |
| other | Hypoesthesia | Nervous system disorders | PZ-128 0.5 mg/kg | 1 | 31 | 1 |
| other | Paresthesia Oral | Nervous system disorders | Placebo | 0 | 35 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 35 |
| Total, all-cause mortality | PZ-128 0.3 mg/kg | 0 | 31 |
| Total, all-cause mortality | PZ-128 0.5 mg/kg | 0 | 31 |
| Total, other adverse events | Placebo | 6 | 35 |
| Total, other adverse events | PZ-128 0.3 mg/kg | 8 | 31 |
| Total, other adverse events | PZ-128 0.5 mg/kg | 16 | 31 |
| Total, serious adverse events | Placebo | 1 | 35 |
| Total, serious adverse events | PZ-128 0.3 mg/kg | 5 | 31 |
| Total, serious adverse events | PZ-128 0.5 mg/kg | 2 | 31 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50HL110789 | TRIP-PCI: PAR1 Pepducin-Based Interventions in Arterial Thrombosis | KULIOPULOS, ATHAN | TUFTS MEDICAL CENTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02561000
GET https://conductscience.org/api/trials/v1/NCT02561000/events?page=2