Coronary Artery DiseasePhase 4STATUS PCINCT01464671
Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention
A Phase 4 study testing Bivalirudin and Heparin in people with Coronary Artery Disease, run by Stony Brook University at 1 site in United States.
Trial summary
The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Bivalirudin and Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is male or female ≥ 18 years of age.
- The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain).
- The patient is scheduled for coronary angiography, with possible angioplasty.
- The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI).
- The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
- The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study.
- Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
Who cannot join
- Patients in cardiogenic shock.
- Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI.
- Known history of heparin-induced thrombocytopenia.
- Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent.
- Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study.
- Pregnant women or nursing mothers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
Official title: STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention
The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI).
The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.
Read the detailed description
The purpose of this study is to compare in a randomized, controlled, single-blinded, 1:1 fashion UFH versus bivalirudin in patients with stable angina pectoris or silent ischemia undergoing PCI.
Secondary study endpoints will include:
- Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
- Net adverse clinical events (NACE) will be consistent of MACE plus major bleeding as defined by the REPLCE-2 criteria.
- Cardiac death in-hospital and up to 30 days post discharge.
- MI in-hospital and up to 30 days post discharge.
- CVA in-hospital and up to 30 days post discharge.
- Incidence of all-cause mortality at 6 months and 1 year.
- MACE at 6 months and 1 year.
- Incidence of acute (0-24 hours post procedure) stent thrombosis rates.
- Incidence of sub-acute (24 hours - 30 days) stent thrombosis rates.
- Length of hospital stay (LOS)
- Economic analysis (total cost during hospitalization) and up to 30 days post discharge.
- Conditions
- Coronary Artery Disease
- Being tested
- Bivalirudin, Heparin
- Keywords
- Coronary Artery Disease, Stable Angina, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Also called Angiomax
Anticoagulation during percutaneous coronary intervention
HeparinDrug
Anticoagulation during percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Bivalirudin | Active comparator | Anticoagulation during percutaneous coronary intervention Receives: Drug: Bivalirudin; Drug: Heparin |
| Unfractionated Heparin | Active comparator | Anticoagulation during percutaneous coronary intervention Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding events
The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition during the index hospitalization and up to 30 days post discharge.
Measured: 30 days
Secondary outcomes (1)
MACE
Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startJul 2009
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: DSMB halted the study early due to futility. There were no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allen Jeremias, Stony Brook University
- Investigators
- Allen Jeremias, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464671
- Sponsor's protocol ID
- 119778 (IRB ID)
- Acronym
- STATUS PCI
- Status last verified
- Nov 2014
- First submitted
- 31 Oct 2011
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01464671
- Acronym / sponsor ID
- STATUS PCI / 119778 (IRB ID)
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Stable Angina, Percutaneous Coronary Intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB halted the study early due to futility. There were no safety concerns.
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Nov 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 objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI).
The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.
Detailed description
The purpose of this study is to compare in a randomized, controlled, single-blinded, 1:1 fashion UFH versus bivalirudin in patients with stable angina pectoris or silent ischemia undergoing PCI.
Secondary study endpoints will include:
- Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
- Net adverse clinical events (NACE) will be consistent of MACE plus major bleeding as defined by the REPLCE-2 criteria.
- Cardiac death in-hospital and up to 30 days post discharge.
- MI in-hospital and up to 30 days post discharge.
- CVA in-hospital and up to 30 days post discharge.
- Incidence of all-cause mortality at 6 months and 1 year.
- MACE at 6 months and 1 year.
- Incidence of acute (0-24 hours post procedure) stent thrombosis rates.
- Incidence of sub-acute (24 hours - 30 days) stent thrombosis rates.
- Length of hospital stay (LOS)
- Economic analysis (total cost during hospitalization) and up to 30 days post discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Active comparator | Drug: Bivalirudin, Drug: HeparinAnticoagulation during percutaneous coronary intervention |
| Unfractionated Heparin | Active comparator | Drug: HeparinAnticoagulation during percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is male or female ≥ 18 years of age.
- The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain).
- The patient is scheduled for coronary angiography, with possible angioplasty.
- The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI).
- The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
Key exclusion criteria (6 listed)
- Patients in cardiogenic shock.
- Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI.
- Known history of heparin-induced thrombocytopenia.
- Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent.
- Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal 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 |
|---|---|---|
| BivalirudinAlso: AngiomaxAnticoagulation during percutaneous coronary intervention | Drug | Bivalirudin |
| HeparinAnticoagulation during percutaneous coronary intervention | Drug | Bivalirudin, Unfractionated Heparin |
Primary outcome
Bleeding events
Time frame: 30 days
The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition during the index hospitalization and up to 30 days post discharge.
1 secondary outcome
MACE
Time frame: 1 year
Results and safety
The study was stopped early (reason given: DSMB halted the study early due to futility. There were no safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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.
Allen Jeremias, MD principal investigator
Stony Brook University
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 Bivalirudin and Heparin in people with Coronary Artery Disease, run by Stony Brook University 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 7 inclusion and 6 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 Nov 2014. 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: DSMB halted the study early due to futility. There were no safety concerns.). 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?
Bleeding events (time frame: 30 days). 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 Nov 2014.