Coronary Artery DiseasePhase 4NCT00589862
Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents
A Phase 4 study testing Plavix (Clopidogrel) in people with Coronary Artery Disease, run by Creighton University at 1 site in United States.
Trial summary
It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Plavix (Clopidogrel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2008
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Required Coronary Artery Angioplasty with a drug-eluting stent deployment
Who cannot join
- The last drug-eluting stent placed greater than 2 weeks prior
- Aspirin or Plavix (Clopidogrel) allergy or contraindication
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.
- Conditions
- Coronary Artery Disease
- Being tested
- Plavix (Clopidogrel)
- Keywords
- Drug Eluting Stents, Clopidogrel Resistance, Aspirin Resistance
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plavix (Clopidogrel)Drug
150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Plavix (Clopidogrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment
Measured: 3 month intervals up to 12 months
Secondary outcomes (2)
to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance
Measured: 3 month intervals up to 12 months
to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).
Measured: 3 month intervals up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Failure to secure adequate funding
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Hilleman, PharmD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589862
- Sponsor's protocol ID
- 07-14622
- Other IDs
- 07-14622
- Status last verified
- Nov 2015
- First submitted
- 28 Dec 2007
- Last updated
- 30 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents
- ClinicalTrials.gov ID
- NCT00589862
- Acronym / sponsor ID
- 07-14622
- Conditions
- Coronary Artery Disease
- Keywords
- Drug Eluting Stents, Clopidogrel Resistance, Aspirin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to secure adequate funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Jan 2008 (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.
It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Plavix (Clopidogrel) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Required Coronary Artery Angioplasty with a drug-eluting stent deployment
Key exclusion criteria (2 listed)
- The last drug-eluting stent placed greater than 2 weeks prior
- Aspirin or Plavix (Clopidogrel) allergy or contraindication
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 |
|---|---|---|
| Plavix (Clopidogrel)150 mg tablet of Plavix (Clopidogrel) per day for 12 months if resistance is identified | Drug | 1 |
Primary outcome
to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment
Time frame: 3 month intervals up to 12 months
2 secondary outcomes
to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance
Time frame: 3 month intervals up to 12 months
to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).
Time frame: 3 month intervals up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
Related trials for Coronary Artery Disease
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
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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 Hilleman, PharmD principal investigator
Creighton 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 Plavix (Clopidogrel) in people with Coronary Artery Disease, run by Creighton 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 30 Nov 2015. 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 withdrawn before enrolling participants, so there are no results.
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?
to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment (time frame: 3 month intervals up to 12 months). 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 30 Nov 2015.