Unstable AnginaPhase 3NCT00250471
PROTECT-TIMI 30 Trial
A Phase 3 study testing Percutaneous Coronary Intervention (PCI) in people with Unstable Angina, run by Millennium Pharmaceuticals, Inc..
Trial summary
The primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unstable Angina
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Sep 2004
- Phase
- Phase 3
- 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
- Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:
- diabetes
- elevated cardiac proteins in the blood (indicating acute coronary syndrome)
- Be willing and able to give informed consent
Who cannot join
- uncontrolled hypertension
- cardiac episode (heart attack) within the previous 24 hours before randomization into the trial
- prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial
- any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read
About this study
Official title: A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents
The primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.
Read the detailed description
Platelet inhibitor drugs
- Conditions
- Unstable Angina
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- GP IIb/IIIa inhibitors, eptifibatide, Anti-thrombotic agents
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Improved Coronary Flow Reserve
Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
Secondary outcomes (2)
Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startMay 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unstable AnginaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250471
- Sponsor's protocol ID
- 03-046
- Status last verified
- Nov 2005
- First submitted
- 7 Nov 2005
- Last updated
- 8 Nov 2005
- Results posted
- No
Publications
Wilson SR, Sabatine MS, Braunwald E, Sloan S, Murphy SA, Morrow DA. Detection of myocardial injury in patients with unstable angina using a novel nanoparticle cardiac troponin I assay: observations from the PROTECT-TIMI 30 Trial. Am Heart J. 2009 Sep;158(3):386-91. doi: 10.1016/j.ahj.2009.06.011. Epub 2009 Jul 15.
PubMed 19699861
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents
- ClinicalTrials.gov ID
- NCT00250471
- Acronym / sponsor ID
- 03-046
- Conditions
- Unstable Angina
- Keywords
- GP IIb/IIIa inhibitors, eptifibatide, Anti-thrombotic agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Sep 2004
- First posted
- 8 Nov 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 primary purpose of this study was to compare the efficacy and safety of bivalirudin to eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high risk for heart attack and other cardiovascular complications who will undergo surgery to open up blocked arteries in the heart.
Detailed description
Platelet inhibitor drugs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chest paing/discomfort that occurs at rest and lasts at least 10 minutes and have at least one of the following high-risk features:
- Be willing and able to give informed consent
Key exclusion criteria (4 listed)
- uncontrolled hypertension
- cardiac episode (heart attack) within the previous 24 hours before randomization into the trial
- prior heart surgery (PCI) within the previous 2 weeks before randomizing in the trial
- any electorcardogram (ECG) finding that make the Holter monitor for ischemia unable to read
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Procedure or surgery | – |
Primary outcome
Efficacy: Improved Coronary Flow Reserve
Safety: TIMI major hemorrhage within 48 hours after randomizing in the trial or hosptial discharge, which ever occurs first.
2 secondary outcomes
Duration of ischemia on continuous EKG monigoring through 24 hours after surgery.
Composite death, heart attack and any occurance of ischemia based on the Holter monitor recording within 48 hours after randomizing into the trial
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 8 Nov 2005.
- Derived from this study: PubMed 19699861Wilson SR, Sabatine MS, Braunwald E, Sloan S, Murphy SA, Morrow DA. Detection of myocardial injury in patients with unstable angina using a novel nanoparticle cardiac troponin I assay: observations from the PROTECT-TIMI 30 Trial. Am Heart J. 2009 Sep;158(3):386-91. doi: 10.1016/j.ahj.2009.06.011. Epub 2009 Jul 15.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Percutaneous Coronary Intervention (PCI) in people with Unstable Angina, run by Millennium Pharmaceuticals, Inc..
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 4 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 8 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy: Improved Coronary Flow Reserve. The study lists 2 primary outcomes in all. 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 NCT00250471, which also lists 1 linked publication.
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 8 Nov 2005.