Percutaneous Coronary InterventionPhase 2NCT01312935
Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
A Phase 2 study testing PMX-60056 in people with Percutaneous Coronary Intervention and Coronary Artery Disease (CAD), run by PolyMedix, Inc. at 3 sites in United States.
Trial summary
The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Artery Disease (CAD), Angioplasty
- What is being tested?
- PMX-60056
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2011to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient will undergo PCI for diagnostic and/or therapeutic purposes with a procedure that uses anticoagulation before the instrumentation and reversal of anticoagulation immediately after the procedure.
- Male or female patients of any race, aged 18-80 years old.
- The patient will be anti-coagulated with unfractionated heparin.
- The patient is medically stable and physically and mentally able to participate in this study.
- The patient has given written informed consent to participate in this study after fully understanding the implications and constraints of the protocol.
Who cannot join
- The patient requires emergency surgery under conditions which prevent compliance with this protocol or which might cause unacceptable risk to the patient.
- The patient requires any concomitant surgical procedures (e.g., carotid artery, CABG) during the PCI.
- The patient has received any investigational drug within 30 days of study enrollment, or has had any prior exposure to PMX-60056.
- The patient has any condition or abnormality which may, in the opinion of the Investigator, compromise the safety of the patient.
- The patient is pregnant or breast feeding.
- The patient is of childbearing potential and not under adequate contraceptive protection.
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- The patient has a history of clinically significant hematologic disease including heparin-induced thrombocytopenia, bleeding disorders, or platelet count <100,000.
- Severe impaired hepatic function (SGOT, SGPT >2 x ULN).
- History of AIDS, ± HIV.
- History of allergy to heparin (beef or pig), protamine, or salmon.
- History of chronic alcohol or drug abuse within the last one year.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Detroit, Michigan
Study site
Rapid City, South Dakota
Study site
South Bend, Indiana
About this study
Official title: A Phase 2 Proof of Concept Study of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Read the detailed description
PMX-60056 is being developed as a rapid and effective reversal agent for use in those situations where anticoagulation by heparin, or LMWH must be quickly stopped. Potential uses include reversal of anticoagulation induced to prevent clotting during surgical procedures, and rescue from cases of inadvertent or unexpected overdose.
- Being tested
- PMX-60056
- Keywords
- Percutaneous Coronary Intervention, Heparin, Angioplasty, LMWH
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMX-60056Drug
investigational drug
| Study group | Role | What they receive |
|---|---|---|
| Heparin and PMX-60056 | Experimental | Not described Receives: Drug: PMX-60056 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this study is the ability to reverse the anticoagulant effects of heparin (as measured by ACT) to the same extent as is known for protamine. intravenous infusion of PMX-60056.
Measured: Immediately post completion of PCI procedure, until 2 hours after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyMedix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312935
- Sponsor's protocol ID
- PMX56-203
- Status last verified
- May 2012
- First submitted
- 8 Mar 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Proof of Concept Study of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT01312935
- Acronym / sponsor ID
- PMX56-203
- Keywords
- Percutaneous Coronary Intervention, Heparin, Angioplasty, LMWH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PolyMedix, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the safety and efficacy of PMX-60056 for the Reversal of Heparin in Patients Undergoing Percutaneous Coronary Intervention (PCI)
Detailed description
PMX-60056 is being developed as a rapid and effective reversal agent for use in those situations where anticoagulation by heparin, or LMWH must be quickly stopped. Potential uses include reversal of anticoagulation induced to prevent clotting during surgical procedures, and rescue from cases of inadvertent or unexpected overdose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heparin and PMX-60056 | Experimental | Drug: PMX-60056 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient will undergo PCI for diagnostic and/or therapeutic purposes with a procedure that uses anticoagulation before the instrumentation and reversal of anticoagulation immediately after the procedure.
- Male or female patients of any race, aged 18-80 years old.
- The patient will be anti-coagulated with unfractionated heparin.
- The patient is medically stable and physically and mentally able to participate in this study.
- The patient has given written informed consent to participate in this study after fully understanding the implications and constraints of the protocol.
Key exclusion criteria (11 listed)
- The patient requires emergency surgery under conditions which prevent compliance with this protocol or which might cause unacceptable risk to the patient.
- The patient requires any concomitant surgical procedures (e.g., carotid artery, CABG) during the PCI.
- The patient has received any investigational drug within 30 days of study enrollment, or has had any prior exposure to PMX-60056.
- The patient has any condition or abnormality which may, in the opinion of the Investigator, compromise the safety of the patient.
- The patient is pregnant or breast feeding.
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 |
|---|---|---|
| PMX-60056investigational drug | Drug | Heparin and PMX-60056 |
Primary outcome
The primary outcome measure of this study is the ability to reverse the anticoagulant effects of heparin (as measured by ACT) to the same extent as is known for protamine. intravenous infusion of PMX-60056.
Time frame: Immediately post completion of PCI procedure, until 2 hours after last dose.
Results and safety
The study was stopped early (reason given: PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 PMX-60056 in people with Percutaneous Coronary Intervention and Coronary Artery Disease (CAD), run by PolyMedix, Inc. 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 17 May 2012. 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. 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?
The study was stopped early (reason given: PolyMedix decided to stop enrollment in both clinical trials due to observations of reductions in blood pressure.). Results are not available in the source record.
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?
The primary outcome measure of this study is the ability to reverse the anticoagulant effects of heparin (as measured by ACT) to the same extent as is known for protamine. intravenous infusion of PMX-60056. (time frame: Immediately post completion of PCI procedure, until 2 hours after last dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2012.