Myocardial InfarctionSCORENCT00781573
Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
A study testing Clopidogrel in people with Myocardial Infarction, run by North Texas Veterans Healthcare System at 3 sites in 3 countries.
Trial summary
Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been established after bare metal stent implantation in the blood vessels of the heart, there is lack of consensus regarding the optimal duration of therapy after implantation of a drug eluting stents (DES). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 11 Sep 2008to 3 Mar 2014
- Phase
- Interventional
- 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
- Post-PCI patients receiving at least 1 DES
- Completed 9-15 months follow-up free of MI, repeat revascularization
- Able to provide informed consent
- Have continued dual anti-platelet therapy with aspirin and clopidogrel for 1 year post-PCI
Who cannot join
- Patients allergic to aspirin
- Patients with aspirin resistance
- Patients with allergy to clopidogrel
- Patients on concomitant warfarin therapy
- History of bleeding diathesis, coagulopathy, and/or platelet count < 100,000 cubic mm
- Patients with a life expectancy less than 1 year due to active cancers (except basal cell carcinoma)
- Pregnancy
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been established after bare metal stent implantation in the blood vessels of the heart, there is lack of consensus regarding the optimal duration of therapy after implantation of a drug eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel use for at least one year in the absence of contraindications after DES implantation, while recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy (that is beyond the current 1 year recommendation) may increase bleeding complication, it may reduce the rates of adverse cardiovascular events like heart attacks and repeat revascularization procedures. A clinical trial which randomizes patients with an uneventful one year course after a DES implantation, to an additional year of clopidogrel and aspirin therapy versus aspirin alone, will be able to answer the important question about the role of extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. The investigators hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is associated with an increase in cardiovascular events during the one year of follow-up period.
Read the detailed description
SCORE is a multicenter, prospective randomized study of post-percutaneous coronary intervention (PCI) patients with an uneventful 1 year post-PCI course on dual anti-platelet therapy (DAPT) with clopidogrel and aspirin. Patient will be randomized to an additional 1 year of DAPT (treatment arm) vs. aspirin alone (control arm)to assess the following endpoints during the 1 year follow-up period:
- Death / Myocardial infarction (MI) (Primary end-point)
- Combined endpoints of death, myocardial infarction, repeat revascularization, stroke, and major/minor bleeding (Secondary end-point)
During the year of follow up, subjects will be contacted once every three months. This will enable us to track study endpoints in the study population. In addition the patients' medical records will be screened to investigate if any of the aforementioned endpoints have been reached.
- Conditions
- Myocardial Infarction
- Being tested
- Clopidogrel
- Keywords
- Drug Eluting Stent, Clopidogrel, Optimal duration of clopidogrel post DES stent implantation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
Clopidogrel, 75 mg QD, for one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clopidogrel (75 mg/day) is continued for another year at the completion of the initial year of clopidogrel and aspirin administration post DES implantation Receives: Drug: Clopidogrel |
| 2 | No intervention | Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death and Myocardial Infarction
Measured: 12 months
Secondary outcomes (1)
Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study start11 Sep 2008
- Primary completion3 Mar 2014
- Study completion3 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Subhash Banerjee, North Texas Veterans Healthcare System
- Investigators
- Subhash Banerjee, MD, Principal investigator, VA North Texas Healthcare System, UT Southwestern Medical CenterEmmanouil S Brilakis, MD, PhD, Study director, VA North Texas Healthcare System, Dallas, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781573
- Sponsor's protocol ID
- Dallas VA IRB #08-048
- Acronym
- SCORE
- Status last verified
- Sep 2018
- First submitted
- 28 Oct 2008
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Banerjee S, Varghese C, Samuel J, Weideman RA, Little BB, Kelly KC, Rao SV, Reilly RF, Brilakis ES. Comparison of the impact of short (<1 year) and long-term (> or =1 year) clopidogrel use following percutaneous coronary intervention on mortality. Am J Cardiol. 2008 Nov 1;102(9):1159-62. doi: 10.1016/j.amjcard.2008.06.058. Epub 2008 Sep 11.
PubMed 18940284Ho PM, Peterson ED, Wang L, Magid DJ, Fihn SD, Larsen GC, Jesse RA, Rumsfeld JS. Incidence of death and acute myocardial infarction associated with stopping clopidogrel after acute coronary syndrome. JAMA. 2008 Feb 6;299(5):532-9. doi: 10.1001/jama.299.5.532.
PubMed 18252883
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Optimal Clopidogrel Duration in Patients Receiving Drug Eluting Stents (SCORE Trial)
- ClinicalTrials.gov ID
- NCT00781573
- Acronym / sponsor ID
- SCORE / Dallas VA IRB #08-048
- Conditions
- Myocardial Infarction
- Keywords
- Drug Eluting Stent, Clopidogrel, Optimal duration of clopidogrel post DES stent implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- 11 Sep 2008 (actual)
- Primary completion
- 3 Mar 2014 (actual)
- Study completion
- 3 Mar 2014 (actual)
- First posted
- 29 Oct 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.
Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been established after bare metal stent implantation in the blood vessels of the heart, there is lack of consensus regarding the optimal duration of therapy after implantation of a drug eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel use for at least one year in the absence of contraindications after DES implantation, while recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy (that is beyond the current 1 year recommendation) may increase bleeding complication, it may reduce the rates of adverse cardiovascular events like heart attacks and repeat revascularization procedures. A clinical trial which randomizes patients with an uneventful one year course after a DES implantation, to an additional year of clopidogrel and aspirin therapy versus aspirin alone, will be able to answer the important question about the role of extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. The investigators hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is associated with an increase in cardiovascular events during the one year of follow-up period.
Detailed description
SCORE is a multicenter, prospective randomized study of post-percutaneous coronary intervention (PCI) patients with an uneventful 1 year post-PCI course on dual anti-platelet therapy (DAPT) with clopidogrel and aspirin. Patient will be randomized to an additional 1 year of DAPT (treatment arm) vs. aspirin alone (control arm)to assess the following endpoints during the 1 year follow-up period:
- Death / Myocardial infarction (MI) (Primary end-point)
- Combined endpoints of death, myocardial infarction, repeat revascularization, stroke, and major/minor bleeding (Secondary end-point)
During the year of follow up, subjects will be contacted once every three months. This will enable us to track study endpoints in the study population. In addition the patients' medical records will be screened to investigate if any of the aforementioned endpoints have been reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ClopidogrelClopidogrel (75 mg/day) is continued for another year at the completion of the initial year of clopidogrel and aspirin administration post DES implantation |
| 2 | No intervention | –Clopidogrel (75 mg/day) is stopped at the completion of the initial year of clopidogrel and aspirin administration post DES implantation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-PCI patients receiving at least 1 DES
- Completed 9-15 months follow-up free of MI, repeat revascularization
- Able to provide informed consent
- Have continued dual anti-platelet therapy with aspirin and clopidogrel for 1 year post-PCI
Key exclusion criteria (7 listed)
- Patients allergic to aspirin
- Patients with aspirin resistance
- Patients with allergy to clopidogrel
- Patients on concomitant warfarin therapy
- History of bleeding diathesis, coagulopathy, and/or platelet count < 100,000 cubic mm
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 |
|---|---|---|
| ClopidogrelClopidogrel, 75 mg QD, for one year | Drug | 1 |
Primary outcome
Death and Myocardial Infarction
Time frame: 12 months
1 secondary outcome
Combined endpoints of death, myocardial infarction, repeat revascularization, stroke and major/minor bleeding
Time frame: 12 months
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 13 Sep 2018.
- Background: PubMed 18940284Banerjee S, Varghese C, Samuel J, Weideman RA, Little BB, Kelly KC, Rao SV, Reilly RF, Brilakis ES. Comparison of the impact of short (<1 year) and long-term (> or =1 year) clopidogrel use following percutaneous coronary intervention on mortality. Am J Cardiol. 2008 Nov 1;102(9):1159-62. doi: 10.1016/j.amjcard.2008.06.058. Epub 2008 Sep 11.
- Background: PubMed 18252883Ho PM, Peterson ED, Wang L, Magid DJ, Fihn SD, Larsen GC, Jesse RA, Rumsfeld JS. Incidence of death and acute myocardial infarction associated with stopping clopidogrel after acute coronary syndrome. JAMA. 2008 Feb 6;299(5):532-9. doi: 10.1001/jama.299.5.532.
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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.
Subhash Banerjee, MD principal investigator
VA North Texas Healthcare System, UT Southwestern Medical Center
Emmanouil S Brilakis, MD, PhD study director
VA North Texas Healthcare System, Dallas, TX
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clopidogrel in people with Myocardial Infarction, run by North Texas Veterans Healthcare System at 3 sites in 3 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 4 inclusion and 7 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Greece, India. 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.
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?
Death and Myocardial Infarction (time frame: 12 months). 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 NCT00781573, which also lists 2 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 13 Sep 2018.