AngioplastyPhase 4NCT00289601
Randomized Study of Aspirin Resistant Patients Undergoing Angioplasty
A Phase 4 study testing eptifibatide in people with Angioplasty, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Angioplasty
- What is being tested?
- eptifibatide
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2007
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease will be eligible for the study. Inclusion criteria are:
- Patient is 21 years or older. Patient is scheduled to undergo low-medium risk percutaneous coronary intervention in native coronary vessels.
- Patient self-reports that he/she has received aspirin ≥ 81 mg at least 4 hours prior to study screening.
- Patient is defined as aspirin non-responsive based upon results of the VerifyNow™ Aspirin test, defined as an aspirin reaction units (ARU) > 475.
- Patient is defined as clopidogrel non-responsive based upon the results of the VerifyNow P2Y12 test, defined as less than 20% inhibition.
- Patient will be treated with 300- 600 mg of clopidogrel at least two hours before the intervention.
- All patients will provide written informed consent, and the study protocol will be approved by the IRB of the participating centers.
- Patient is male, or is a non-pregnant female.
Who cannot join
- Patient has a known allergic reaction to the study medication. Patient has been diagnosed with a myocardial infarction within the prior 7 days.
- Patient has unstable angina, defined as dynamic, ischemic ECG changes (ST-segment elevation, ST-segment depression, or T-wave inversion) at rest.
- Patient has rest pain with left bundle branch block. Note: In a patient with rest pain and abnormal ECG that is believed to be non-acute (i.e., STTW abnormalities secondary to LVH, digoxin, or prior remote infarction), a second electrocardiogram 30 min apart is required to establish that these changes are non-dynamic and not indicative of active ischemia.
- The target lesion(s) is located in a venous bypass graft. The patient has a chronic occlusion (present for longer than 3 months). The target lesion(s) has visible thrombus (by angiography). The patient has had a suspected aortic dissection. Patient has left ventricular ejection (LVEF) < 30%. Patient was receiving oral anticoagulation therapy.
- Patient received any of the following drugs during 7 days prior to enrollment:
- any GP IIb/IIIa inhibitor
Show all 14Show fewer
- ticlopidine
- dipyridamole
- cilostazol (Pletal) Patient has received non-steroidal anti-inflammatory drugs (NSAIDS), or any steroidal drugs 24 hours prior to enrollment.
- Patient has been diagnosed with any stroke within the prior 3 months. Patient has active bleeding or bleeding diathesis. Patient has experienced trauma or major surgery in the preceding month. Patient has severe, uncontrolled hypertension (systolic blood pressure of more than 180 mm Hg).
- Patient's creatinine > 2.0 mg/dl prior to PCI. Patient has a hemoglobin level of less than 10.0 g per deciliter or a hematocrit below 30 percent.
- Patient has a platelet count of less than 100,000 per cubic millimeter or more than 600,000 per cubic millimeter.
- Of note, patients on chronic clopidogrel will only be eligible for VerifyNow P2Y12 testing. Clopidogrel non-responsiveness in this group will be defined as < 20% inhibition
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Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Research Evaluation to Study Individuals Who Show Thromboxane Or P2Y12 Receptor Resistance
This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI. The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24 hours of low-medium risk PCI in patients who are aspirin or non-responsive as determined by VerifyNow Aspirin and P2Y12 testing.
Read the detailed description
The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24 hours of low-medium risk PCI in patients who are aspirin or clopidogrel non-responsive as determined by VerifyNow Aspirin and P2Y12 testing.
Secondary study objectives will include an assessment of safety. These safety determinations will be determined by monitoring the rates of MACE (defined as death, MI, ischemic [non-hemorrhagic] stroke and urgent revascularization by repeat PCI or CABG), bleeding events, rate of bailout procedures performed, elevations of CK-MB ratio (in the range of 3 to 5 times ULN and greater than 5 times ULN) and elevations of troponin I.
This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI. All subjects must also be pretreated with clopidogrel (300-600 mg) at least 2 hours before PCI. Study subjects will be randomized to either eptifibatide and unfractionated heparin or unfractionated heparin and placebo. Study subject randomization in aspirin non-responsive patients will be stratified based upon clopidogrel responsiveness.
- Conditions
- Angioplasty
- Being tested
- eptifibatide
- Keywords
- aspirin, clopidogrel, resistance, angioplasty, percutaneous coronary intervention, myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptifibatideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the incidence of myonecrosis, defined as an elevation in creatinine kinase - myocardial band (CK-MB) > 2 x IU/ml above the institution's upper limit of normal within 24 hours following low-medium risk PCI.
Secondary outcomes (6)
Incidence of CK-MB elevation >3x ULN
Incidence of CK-MB elevation to 3-5x ULN
Incidence of CK-MB elevation >5x ULN
Incidence of troponin I > 0.1ng/ml
MACE rates reported at discharge, 30 days and 6 months. (MACE is defined as a composite endpoint of death, MI, ischemic (non-hemorrhagic) stroke, and urgent target vessel revascularization)
Rate of bail-out use of eptifibatide/placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startMar 2006
- Study completionDec 2007
Why it stopped: Sponsor support withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Daniel I Simon, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289601
- Sponsor's protocol ID
- RESISTOR
- Status last verified
- Jul 2007
- First submitted
- 8 Feb 2006
- Last updated
- 20 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Evaluation to Study Individuals Who Show Thromboxane Or P2Y12 Receptor Resistance
- ClinicalTrials.gov ID
- NCT00289601
- Acronym / sponsor ID
- RESISTOR
- Conditions
- Angioplasty
- Keywords
- aspirin, clopidogrel, resistance, angioplasty, percutaneous coronary intervention, myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor support withdrawn
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Mar 2006
- Study completion
- Dec 2007
- First posted
- 10 Feb 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.
This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI. The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24 hours of low-medium risk PCI in patients who are aspirin or non-responsive as determined by VerifyNow Aspirin and P2Y12 testing.
Detailed description
The primary objective of this study is to determine if the use of eptifibatide is associated with a significant difference in post-PCI myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times upper limit of normal [ULN]) within 24 hours of low-medium risk PCI in patients who are aspirin or clopidogrel non-responsive as determined by VerifyNow Aspirin and P2Y12 testing.
Secondary study objectives will include an assessment of safety. These safety determinations will be determined by monitoring the rates of MACE (defined as death, MI, ischemic [non-hemorrhagic] stroke and urgent revascularization by repeat PCI or CABG), bleeding events, rate of bailout procedures performed, elevations of CK-MB ratio (in the range of 3 to 5 times ULN and greater than 5 times ULN) and elevations of troponin I.
This study is a randomized, double-blind, multi-center study designed to compare differences in rates of myonecrosis (measured as an elevation of CK-MB ratio ≥ 2 times ULN) within 24 hours following low-medium risk percutaneous coronary intervention (PCI) in aspirin or clopidogrel non-responsive patients who are randomized to heparin with or without eptifibatide therapy during PCI. All subjects must also be pretreated with clopidogrel (300-600 mg) at least 2 hours before PCI. Study subjects will be randomized to either eptifibatide and unfractionated heparin or unfractionated heparin and placebo. Study subject randomization in aspirin non-responsive patients will be stratified based upon clopidogrel responsiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with coronary artery disease will be eligible for the study. Inclusion criteria are:
- Patient is 21 years or older. Patient is scheduled to undergo low-medium risk percutaneous coronary intervention in native coronary vessels.
- Patient self-reports that he/she has received aspirin ≥ 81 mg at least 4 hours prior to study screening.
- Patient is defined as aspirin non-responsive based upon results of the VerifyNow™ Aspirin test, defined as an aspirin reaction units (ARU) > 475.
- Patient is defined as clopidogrel non-responsive based upon the results of the VerifyNow P2Y12 test, defined as less than 20% inhibition.
Key exclusion criteria (14 listed)
- Patient has a known allergic reaction to the study medication. Patient has been diagnosed with a myocardial infarction within the prior 7 days.
- Patient has unstable angina, defined as dynamic, ischemic ECG changes (ST-segment elevation, ST-segment depression, or T-wave inversion) at rest.
- Patient has rest pain with left bundle branch block. Note: In a patient with rest pain and abnormal ECG that is believed to be non-acute (i.e., STTW abnormalities secondary to LVH, digoxin, or prior remote infarction), a second electrocardiogram 30 min apart is required to establish that these changes are non-dynamic and not indicative of active ischemia.
- The target lesion(s) is located in a venous bypass graft. The patient has a chronic occlusion (present for longer than 3 months). The target lesion(s) has visible thrombus (by angiography). The patient has had a suspected aortic dissection. Patient has left ventricular ejection (LVEF) < 30%. Patient was receiving oral anticoagulation therapy.
- any GP IIb/IIIa inhibitor
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 |
|---|---|---|
| eptifibatide | Drug | – |
Primary outcome
The primary endpoint is the incidence of myonecrosis, defined as an elevation in creatinine kinase - myocardial band (CK-MB) > 2 x IU/ml above the institution's upper limit of normal within 24 hours following low-medium risk PCI.
6 secondary outcomes
Incidence of CK-MB elevation >3x ULN
Incidence of CK-MB elevation to 3-5x ULN
Incidence of CK-MB elevation >5x ULN
Incidence of troponin I > 0.1ng/ml
MACE rates reported at discharge, 30 days and 6 months. (MACE is defined as a composite endpoint of death, MI, ischemic (non-hemorrhagic) stroke, and urgent target vessel revascularization)
Rate of bail-out use of eptifibatide/placebo.
Results and safety
The study was stopped early (reason given: Sponsor support withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2007.
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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.
Daniel I Simon, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing eptifibatide in people with Angioplasty, run by Brigham and Women's Hospital at 1 site 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 8 inclusion and 14 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 20 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Sponsor support withdrawn). 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 endpoint is the incidence of myonecrosis, defined as an elevation in creatinine kinase - myocardial band (CK-MB) > 2 x IU/ml above the institution's upper limit of normal within 24 hours following low-medium risk PCI.. 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 20 Jul 2007.