Heart DiseasesPhase 2NCT00271167
A Trial of INO-1001 in Patients Undergoing Heart Surgery That Involves Heart-lung Bypass
A Phase 2 study testing INO-1001 in people with Heart Diseases and Postoperative Complications, run by Inotek Pharmaceuticals Corporation at 13 sites in 4 countries.
Trial summary
The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Diseases, Postoperative Complications
- What is being tested?
- INO-1001
- How many people
- 162 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Oct 2005to 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
- 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 to mannitol
- Participation in any other investigational study within 30 days of the screening phase
- Known alcohol or drug abuse within the last year
- Treatment with certain restricted medications within a specified time prior to participation in the study
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Methodist Hospital
Houston, Texas, 77030
University of Oklahoma
Oklahoma City, Oklahoma, 73152
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rapid City Regional Hospital
Rapid City, South Dakota
Australia4 sites
Ashford Cardiac Clinic / Adelaide Cardiac
Adelaide, South Australia
St. Vincent's Hospital
Melbourne, Victoria, 3065
Royal Perth Hospital
Perth, Western Australia, 6000
Study site
Sydney, New South Wales
India2 sites
Care Hospital
Hyderabad
Escorts Heart Institute and Research Centre
New Delhi, 110029
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Tolerability, Safety, Pharmacokinetics and Efficacy of Intravenous INO-1001 in High Risk Subjects Undergoing Cardiopulmonary Bypass for Coronary Revascularization and/or Valve Surgery.
The purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines.
Read the detailed description
Heart-lung bypass during heart surgery sometimes leads to side effects or complications after surgery.
Studies have shown that PARP inhibitors protect cells from damage due to lack of oxygen. Heart-lung bypass during heart surgery can result in cells being deprived of oxygen. INO-1001 may be able to protect these cells and reduce complications following surgery.
A total of 162 patients will be randomly assigned to either INO-1001 or placebo (sugar water). Treatment will begin on the day of heart surgery and continue for 36 hours. A total of 4 doses of INO-1001 will be given. Patients will be followed up until 30 days after surgery.
The following information will be collected: symptoms, vital signs, 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
- Heart Diseases, Postoperative Complications
- Being tested
- INO-1001
- Keywords
- Cardiac surgery, PARP inhibitor, PARP inhibition, Bypass surgery, CPB surgery, Cardiopulmonary bypass, Coronary revascularization, Cardiac valve replacement
- Medical subject headings
- Heart Diseases, Postoperative Complications
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.
Reduction in serious post-operative complications occurring in the first thirty days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startOct 2005
- Study completionJun 2006
Why it stopped: It was determined that the study was not appropriate for demonstrating therapeutic benefit in the cardiopulmonary bypass patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart 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
- Double blind
- Enrolment
- 162 participants
Sponsor and investigators
- Lead sponsor
- Inotek Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271167
- Sponsor's protocol ID
- IPC-05-2004
- Status last verified
- Mar 2015
- First submitted
- 29 Dec 2005
- Last updated
- 25 Mar 2015
- Results posted
- No
Publications
Khan TA, Ruel M, Bianchi C, Voisine P, Komjati K, Szabo C, Sellke FW. Poly(ADP-ribose) polymerase inhibition improves postischemic myocardial function after cardioplegia-cardiopulmonary bypass. J Am Coll Surg. 2003 Aug;197(2):270-7. doi: 10.1016/S1072-7515(03)00538-6.
PubMed 12892811Virag L, Szabo C. The therapeutic potential of poly(ADP-ribose) polymerase inhibitors. Pharmacol Rev. 2002 Sep;54(3):375-429. doi: 10.1124/pr.54.3.375.
PubMed 12223530Szabo C. Pharmacological inhibition of poly(ADP-ribose) polymerase in cardiovascular disorders: future directions. Curr Vasc Pharmacol. 2005 Jul;3(3):301-3. doi: 10.2174/1570161054368553.
PubMed 16026326
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Tolerability, Safety, Pharmacokinetics and Efficacy of Intravenous INO-1001 in High Risk Subjects Undergoing Cardiopulmonary Bypass for Coronary Revascularization and/or Valve Surgery.
- ClinicalTrials.gov ID
- NCT00271167
- Acronym / sponsor ID
- IPC-05-2004
- Conditions
- Heart Diseases, Postoperative Complications
- Keywords
- Cardiac surgery, PARP inhibitor, PARP inhibition, Bypass surgery, CPB surgery, Cardiopulmonary bypass, Coronary revascularization, Cardiac valve replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was determined that the study was not appropriate for demonstrating therapeutic benefit in the cardiopulmonary bypass patient population.
- Enrolment
- 162 participants
- Lead sponsor
- Inotek Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Dec 2005 (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 purpose of this study is to assess the safety of INO-1001, an intravenous PARP (poly-[ADP ribose] polymerase) inhibitor, in patients undergoing heart surgery. The study also measures whether INO-1001 reduces the side effects caused by heart-lung bypass machines.
Detailed description
Heart-lung bypass during heart surgery sometimes leads to side effects or complications after surgery.
Studies have shown that PARP inhibitors protect cells from damage due to lack of oxygen. Heart-lung bypass during heart surgery can result in cells being deprived of oxygen. INO-1001 may be able to protect these cells and reduce complications following surgery.
A total of 162 patients will be randomly assigned to either INO-1001 or placebo (sugar water). Treatment will begin on the day of heart surgery and continue for 36 hours. A total of 4 doses of INO-1001 will be given. Patients will be followed up until 30 days after surgery.
The following information will be collected: symptoms, vital signs, 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
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to undergo cardiopulmonary bypass for coronary revascularization and/or valve surgery
- Males and non-pregnant, non-lactating females
Key exclusion criteria (5 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 to mannitol
- Participation in any other investigational study within 30 days of the screening phase
- Known alcohol or drug abuse within the last year
- 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
Reduction in serious post-operative complications occurring in the first thirty days after surgery.
Results and safety
The study was stopped early (reason given: It was determined that the study was not appropriate for demonstrating therapeutic benefit in the cardiopulmonary bypass patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Background: PubMed 12892811Khan TA, Ruel M, Bianchi C, Voisine P, Komjati K, Szabo C, Sellke FW. Poly(ADP-ribose) polymerase inhibition improves postischemic myocardial function after cardioplegia-cardiopulmonary bypass. J Am Coll Surg. 2003 Aug;197(2):270-7. doi: 10.1016/S1072-7515(03)00538-6.
- Background: PubMed 12223530Virag L, Szabo C. The therapeutic potential of poly(ADP-ribose) polymerase inhibitors. Pharmacol Rev. 2002 Sep;54(3):375-429. doi: 10.1124/pr.54.3.375.
- Background: PubMed 16026326Szabo C. Pharmacological inhibition of poly(ADP-ribose) polymerase in cardiovascular disorders: future directions. Curr Vasc Pharmacol. 2005 Jul;3(3):301-3. doi: 10.2174/1570161054368553.
Related trials for Heart Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
13 sites in 4 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 Heart Diseases and Postoperative Complications, run by Inotek Pharmaceuticals Corporation at 13 sites in 4 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 2 inclusion and 5 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, India, 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 was stopped early (reason given: It was determined that the study was not appropriate for demonstrating therapeutic benefit in the cardiopulmonary bypass patient population.). 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?
Reduction in serious post-operative complications occurring in the first thirty days after surgery.. 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 NCT00271167, which also lists 3 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 25 Mar 2015.