Acute Myocardial InfarctionPhase 2NCT00271765
A Study of INO-1001, an Intravenous PARP (Poly [ADP Ribose] Polymerase) Inhibitor in Acute Heart Attack Patients Undergoing Primary Percutaneous Coronary Intervention
A Phase 2 study testing INO-1001 in people with Acute Myocardial Infarction, run by Inotek Pharmaceuticals Corporation at 16 sites in 2 countries.
Trial summary
The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- INO-1001
- How many people
- 40 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Jan 2004to Jun 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization.
- Scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study.
- Males and non-pregnant, non-lactating females.
Who cannot join
- Subjects will be required to undergo a full medical review in order to exclude serious medical, or psychological illness prior to inclusion.
- History of a hypersensitivity reaction to more than three drugs or mannitol.
- Participation in any investigational study within 30 days of randomization
- Treatment with certain restricted medications within a specified time prior to participation in the study.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States10 sites
Study site
Burlington, Vermont
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
West Virginia University
Morgantown, West Virginia, 26506
Study site
Newark, New Jersey
Sentara Norfolk General Hospital
Norfolk, Virginia
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania
Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701
St. Paul Heart Clinic
Saint Paul, Minnesota, 55102
Toledo Hospital
Toledo, Ohio, 43606
Porter Hospital
Valparaiso, Indiana, 46383
Israel6 sites
Rambam Medical Center
Haifa, 31096
Meir Medical Center
Kfar Saba, 95847
Hasharon Medical Center
Petah Tikva, 49100
Rabin Medical Center
Petah Tikva, 49100
Study site
Rehovot
Assaf Harofe Medical Centre
Tsrifin
About this study
Official title: A Phase II Randomized, Placebo-Controlled, Single-Blind, Multi-Center Dose-Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Administration of INO-1001 in Subjects With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
The primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.
Read the detailed description
Currently, heart attacks may be treated with clot-dissolving medicines, coronary angioplasty, or a combination of both. Unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage, abnormal heart rhythms and death of heart muscle cells.
In animal studies, the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries. INO-1001 blocks the PARP enzyme, and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack.
A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo (sugar water). One dose only of the drug will be given prior to coronary angioplasty. Patients will be followed until 30 days after surgery.
The following information will be gathered: vital signs, symptoms, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.
The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.
- Conditions
- Acute Myocardial Infarction
- Being tested
- INO-1001
- Keywords
- Myocardial infarction, Coronary angioplasty, PARP inhibitor, PARP inhibition, Heart Attack
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-1001Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.
Secondary outcomes (1)
The effect of INO-1001 on heart muscle damage will be evaluated by blood tests. Other blood tests will measure how INO-1001 is absorbed and removed by the body after exposure to different doses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startJan 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Inotek Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271765
- Sponsor's protocol ID
- IPC-15-2003
- Status last verified
- Nov 2006
- First submitted
- 3 Jan 2006
- Last updated
- 29 Nov 2006
- Results posted
- No
Publications
Liaudet L, Szabo E, Timashpolsky L, Virag L, Cziraki A, Szabo C. Suppression of poly (ADP-ribose) polymerase activation by 3-aminobenzamide in a rat model of myocardial infarction: long-term morphological and functional consequences. Br J Pharmacol. 2001 Aug;133(8):1424-30. doi: 10.1038/sj.bjp.0704185.
PubMed 11498530Zingarelli B, Cuzzocrea S, Zsengeller Z, Salzman AL, Szabo C. Protection against myocardial ischemia and reperfusion injury by 3-aminobenzamide, an inhibitor of poly (ADP-ribose) synthetase. Cardiovasc Res. 1997 Nov;36(2):205-15. doi: 10.1016/s0008-6363(97)00137-5.
PubMed 9463632Zingarelli B, Salzman AL, Szabo C. Genetic disruption of poly (ADP-ribose) synthetase inhibits the expression of P-selectin and intercellular adhesion molecule-1 in myocardial ischemia/reperfusion injury. Circ Res. 1998 Jul 13;83(1):85-94. doi: 10.1161/01.res.83.1.85.
PubMed 9670921Grupp IL, Jackson TM, Hake P, Grupp G, Szabo C. Protection against hypoxia-reoxygenation in the absence of poly (ADP-ribose) synthetase in isolated working hearts. J Mol Cell Cardiol. 1999 Jan;31(1):297-303. doi: 10.1006/jmcc.1998.0864.
PubMed 10072736Morrow DA, Brickman CM, Murphy SA, Baran K, Krakover R, Dauerman H, Kumar S, Slomowitz N, Grip L, McCabe CH, Salzman AL. A randomized, placebo-controlled trial to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamics of a potent inhibitor of poly(ADP-ribose) polymerase (INO-1001) in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the TIMI 37 trial. J Thromb Thrombolysis. 2009 May;27(4):359-64. doi: 10.1007/s11239-008-0230-1. Epub 2008 Jun 6.
PubMed 18535785
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Placebo-Controlled, Single-Blind, Multi-Center Dose-Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Administration of INO-1001 in Subjects With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00271765
- Acronym / sponsor ID
- IPC-15-2003
- Conditions
- Acute Myocardial Infarction
- Keywords
- Myocardial infarction, Coronary angioplasty, PARP inhibitor, PARP inhibition, Heart Attack
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Inotek Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Jun 2006
- First posted
- 4 Jan 2006 (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 primary purpose of this study is to assess the safety of INO-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.
Detailed description
Currently, heart attacks may be treated with clot-dissolving medicines, coronary angioplasty, or a combination of both. Unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage, abnormal heart rhythms and death of heart muscle cells.
In animal studies, the PARP enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries. INO-1001 blocks the PARP enzyme, and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack.
A total of 40 patients will be selected and randomly assigned to either INO-1001 or placebo (sugar water). One dose only of the drug will be given prior to coronary angioplasty. Patients will be followed until 30 days after surgery.
The following information will be gathered: vital signs, symptoms, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts.
The information provided in this listing is disclosed solely to comply with regulatory requirements. The drug INO-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization.
- Scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study.
- Males and non-pregnant, non-lactating females.
Key exclusion criteria (4 listed)
- Subjects will be required to undergo a full medical review in order to exclude serious medical, or psychological illness prior to inclusion.
- History of a hypersensitivity reaction to more than three drugs or mannitol.
- Participation in any investigational study within 30 days of randomization
- Treatment with certain restricted medications within a specified time prior to participation in the study.
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 |
|---|---|---|
| INO-1001 | Drug | – |
Primary outcome
The safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.
1 secondary outcome
The effect of INO-1001 on heart muscle damage will be evaluated by blood tests. Other blood tests will measure how INO-1001 is absorbed and removed by the body after exposure to different doses.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2006.
- Background: PubMed 11498530Liaudet L, Szabo E, Timashpolsky L, Virag L, Cziraki A, Szabo C. Suppression of poly (ADP-ribose) polymerase activation by 3-aminobenzamide in a rat model of myocardial infarction: long-term morphological and functional consequences. Br J Pharmacol. 2001 Aug;133(8):1424-30. doi: 10.1038/sj.bjp.0704185.
- Background: PubMed 9463632Zingarelli B, Cuzzocrea S, Zsengeller Z, Salzman AL, Szabo C. Protection against myocardial ischemia and reperfusion injury by 3-aminobenzamide, an inhibitor of poly (ADP-ribose) synthetase. Cardiovasc Res. 1997 Nov;36(2):205-15. doi: 10.1016/s0008-6363(97)00137-5.
- Background: PubMed 9670921Zingarelli B, Salzman AL, Szabo C. Genetic disruption of poly (ADP-ribose) synthetase inhibits the expression of P-selectin and intercellular adhesion molecule-1 in myocardial ischemia/reperfusion injury. Circ Res. 1998 Jul 13;83(1):85-94. doi: 10.1161/01.res.83.1.85.
- Background: PubMed 10072736Grupp IL, Jackson TM, Hake P, Grupp G, Szabo C. Protection against hypoxia-reoxygenation in the absence of poly (ADP-ribose) synthetase in isolated working hearts. J Mol Cell Cardiol. 1999 Jan;31(1):297-303. doi: 10.1006/jmcc.1998.0864.
- Derived from this study: PubMed 18535785Morrow DA, Brickman CM, Murphy SA, Baran K, Krakover R, Dauerman H, Kumar S, Slomowitz N, Grip L, McCabe CH, Salzman AL. A randomized, placebo-controlled trial to evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamics of a potent inhibitor of poly(ADP-ribose) polymerase (INO-1001) in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the TIMI 37 trial. J Thromb Thrombolysis. 2009 May;27(4):359-64. doi: 10.1007/s11239-008-0230-1. Epub 2008 Jun 6.
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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.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INO-1001 in people with Acute Myocardial Infarction, run by Inotek Pharmaceuticals Corporation at 16 sites in 2 countries.
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 3 inclusion and 4 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 29 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 safety of INO-1001 will be measured by evaluation of symptoms, vital signs, physical examination, laboratory data, electrocardiograms, etc.. 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 NCT00271765, which also lists 5 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 29 Nov 2006.