Coronary DiseasePRACTICE INCT00684359
Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I
An observational study of Coronary Disease, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
Single center randomized parallel group study to determine if: 1. there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2010
- Phase
- Observational
- 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
Study population: Patients, male or female, > 18 years of age; who are scheduled for an elective PCI with a drug eluting stent; willing to return for all required follow up visit and live/work within a 60 mile radius of the Washington Hospital Center.
Who may be able to join
- Patients, male or female, > 18 years of age,
- Patients who are scheduled for an elective PCI with a drug eluting stent
- Patients willing to return for all required follow up visits.
- Patients live/work within a 60 mile radius of the Washington Hospital Center.
Who cannot join
- Patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty.
- Unprotected left main coronary disease with >50% stenosis;
- Patients with renal failure requiring dialysis;
- Patients with a documented ejection fraction < 30 percent at the time of subsequent PCI;
- Patient with a life expectancy less than 12 months or malignancy.
- Known allergies to aspirin or clopidogrel bisulfate (PlavixR) and that cannot be medically managed;
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- Planned surgery or other indication for requiring the cessation of clopidogrel within 12 months of PCI;
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.
- Patients with known history of bleeding diathesis;
- Prothrombin time >1.5 times control; coumadin therapy
- Platelet count <100 000/mm3;
- Hematocrit <25%;
- Creatinine >4.0 mg/dL;
- Thienopyridine use within 5 days of enrollment
- Glycoprotein (GP) IIb/IIIa use within 8 hours of enrollment or any indication were the operator will require GP IIb/IIIa inhibitor use during the hospitalization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ron Waksman, MD, Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Single center randomized parallel group study to determine if:
- there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon.
- the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity. And the association with MACE up to 12 months post coronary angioplasty.
- Conditions
- Coronary Disease
- Keywords
- Patients having PCI with a drug eluting stent
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon
Measured: Up to 12 months
Secondary outcomes (1)
To determine what the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity.
Measured: 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 posted26 May 2008 (estimated)
- Study startJun 2007
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684359
- Sponsor's protocol ID
- PRACTICE I
- Acronym
- PRACTICE I
- Status last verified
- May 2010
- First submitted
- 21 May 2008
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I
- ClinicalTrials.gov ID
- NCT00684359
- Acronym / sponsor ID
- PRACTICE I / PRACTICE I
- Conditions
- Coronary Disease
- Keywords
- Patients having PCI with a drug eluting stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Feb 2010 (actual)
- First posted
- 26 May 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.
Single center randomized parallel group study to determine if:
- there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon.
- the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity. And the association with MACE up to 12 months post coronary angioplasty.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, male or female, > 18 years of age; who are scheduled for an elective PCI with a drug eluting stent; willing to return for all required follow up visit and live/work within a 60 mile radius of the Washington Hospital Center.
Key inclusion criteria (4 listed)
- Patients, male or female, > 18 years of age,
- Patients who are scheduled for an elective PCI with a drug eluting stent
- Patients willing to return for all required follow up visits.
- Patients live/work within a 60 mile radius of the Washington Hospital Center.
Key exclusion criteria (15 listed)
- Patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty.
- Unprotected left main coronary disease with >50% stenosis;
- Patients with renal failure requiring dialysis;
- Patients with a documented ejection fraction < 30 percent at the time of subsequent PCI;
- Patient with a life expectancy less than 12 months or malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon
Time frame: Up to 12 months
1 secondary outcome
To determine what the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity.
Time frame: up to 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 31 May 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Medstar Health Research Institute 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 4 inclusion and 15 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 31 May 2010. 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.
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?
To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon (time frame: 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 31 May 2010.