Acute Myocardial InfarctionNCT01353261
Platelet Function Monitoring in Patients With Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This study is being done to learn more about platelet reactivity (how well the small cells in the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for stable and unstable (acute myocardial infarction) indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2013
- 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: Seventy five subjects (25 patients undergoing elective PCI for stable CAD and 50 patients undergoing urgent PCI for AMI(25 receiving clopidogrel and 25 receiving prasugrel - as determined by the treating physicians)
Who may be able to join
- Patient >18 years old.
- Patient scheduled to undergo PCI for either stable CAD or AMI:
- Stable CAD defined as negative cardiac isoenzymes prior to the PCI as well as no resting ECG changes indicative of ACS.
- AMI defined as positive cardiac isoenzymes prior to the PCI and/or resting ECG changes indicative of ACS.
- 3. Patients treated with a loading dose of clopidogrel at least 6 hours prior to the blood draw or on a maintenance dose of clopidogrel (of at least 75mg QD) for a minimum of 5 days.
Who cannot join
- Known allergies to aspirin, clopidogrel, or prasugrel
- Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of the blood draw;
- Patient known to be pregnant or lactating;
- Patient with known history of bleeding diathesis or currently active bleeding;
- Platelet count <100,000/mm the day of the blood draw;
- Hematocrit <25% the day of the blood draw;
Show all 11Show fewer
- On warfarin therapy at the time of the blood draw or the need for warfarin therapy in the subsequent month following the blood draw;
- Known blood transfusion within the preceding 10 days of the blood draw;
- Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;
- Patients presenting with cardiogenic shock;
- Any significant medical condition, which in the investigator's opinion may interfere with the patient's optimal participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
This study is being done to learn more about platelet reactivity (how well the small cells in the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for stable and unstable (acute myocardial infarction) indications. Stable means you have not demonstrated any acute injury to your heart prior to your PCI; unstable means you have demonstrated some acute injury to your heart prior to your PCI. The investigators intend to determine if there is a change in platelet reactivity from the time of PCI to 30days post-PCI and does this change differ depending upon the conduction in which you present for PCI. This is going to be done with a variety of platelet reactivity assays.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Platelet reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elective Cases | Patients with stable CAD undergoing PCI | |
| AMI Cases treated with clopidogrel | Patient with AMI undergoing PCI | |
| AMI Cases treated with prasugrel | Patients with AMI undergoing PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet function
The primary endpoint will be whether the results of platelet function assays used to measure response to clopidogrel and prasugrel therapy is similar amongst patients with stable CAD and those with AMI undergoing PCI. On-treatment platelet reactivity will be measured using the VerifyNow P2Y12 assay.
Measured: 30 days
Secondary outcomes (1)
On-treatment platelet reactivity
A secondary endpoint will be to determine on-treatment platelet reactivity at the same time points using:
- The vasodilator-stimulated phosphoprotein (VASP) phosphorylation assay; and/or
- The Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353261
- Sponsor's protocol ID
- TIMING
- Status last verified
- Oct 2013
- First submitted
- 11 May 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function Monitoring in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01353261
- Acronym / sponsor ID
- TIMING
- Conditions
- Acute Myocardial Infarction
- Keywords
- Platelet reactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 13 May 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.
This study is being done to learn more about platelet reactivity (how well the small cells in the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for stable and unstable (acute myocardial infarction) indications. Stable means you have not demonstrated any acute injury to your heart prior to your PCI; unstable means you have demonstrated some acute injury to your heart prior to your PCI. The investigators intend to determine if there is a change in platelet reactivity from the time of PCI to 30days post-PCI and does this change differ depending upon the conduction in which you present for PCI. This is going to be done with a variety of platelet reactivity assays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elective Cases | – | –Patients with stable CAD undergoing PCI |
| AMI Cases treated with clopidogrel | – | –Patient with AMI undergoing PCI |
| AMI Cases treated with prasugrel | – | –Patients with AMI undergoing PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seventy five subjects (25 patients undergoing elective PCI for stable CAD and 50 patients undergoing urgent PCI for AMI(25 receiving clopidogrel and 25 receiving prasugrel - as determined by the treating physicians)
Key inclusion criteria (5 listed)
- Patient >18 years old.
- Patient scheduled to undergo PCI for either stable CAD or AMI:
- Stable CAD defined as negative cardiac isoenzymes prior to the PCI as well as no resting ECG changes indicative of ACS.
- AMI defined as positive cardiac isoenzymes prior to the PCI and/or resting ECG changes indicative of ACS.
- 3. Patients treated with a loading dose of clopidogrel at least 6 hours prior to the blood draw or on a maintenance dose of clopidogrel (of at least 75mg QD) for a minimum of 5 days.
Key exclusion criteria (11 listed)
- Known allergies to aspirin, clopidogrel, or prasugrel
- Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of the blood draw;
- Patient known to be pregnant or lactating;
- Patient with known history of bleeding diathesis or currently active bleeding;
- Platelet count <100,000/mm the day of the blood draw;
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
Platelet function
Time frame: 30 days
The primary endpoint will be whether the results of platelet function assays used to measure response to clopidogrel and prasugrel therapy is similar amongst patients with stable CAD and those with AMI undergoing PCI. On-treatment platelet reactivity will be measured using the VerifyNow P2Y12 assay.
1 secondary outcome
On-treatment platelet reactivity
Time frame: 30 days
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 1 Nov 2013.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
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 Acute Myocardial Infarction, 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 5 inclusion and 11 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 1 Nov 2013. 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?
Platelet function (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 1 Nov 2013.