ThrombosisPhase 4NCT01612884
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
A Phase 4 study testing Prasugrel and Clopidogrel in people with Thrombosis and Coronary Artery Disease, run by Indiana University at 2 sites in United States.
Trial summary
Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Thrombosis, Coronary Artery Disease
- What is being tested?
- Prasugrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Mar 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction) and referred for coronary angiography.
- Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for >5 days)
- Age range 21-75 years.
Who cannot join
- Unable to give consent
- Age younger than 21 years, greater than 75 years
- History of stroke
- Body weight <60 kg
- Acute STEMI,
- Thrombocytopenia<100'000,
- requirement for chronic warfarin therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting
- Conditions
- Thrombosis, Coronary Artery Disease
- Being tested
- Prasugrel, Clopidogrel
- Medical subject headings
- Thrombosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
ClopidogrelDrug
Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
| Study group | Role | What they receive |
|---|---|---|
| TEG | Other | Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69 Receives: Drug: Prasugrel; Drug: Clopidogrel |
| Light transmittance aggregometry | Other | Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9% Receives: Drug: Prasugrel; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombelastography (TEG) MA
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
Measured: 1 day
Secondary outcomes (2)
Number of Participants With Ischemic Events
Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention
Measured: 6 months
Number of Participants With Bleeding Events
Major or Minor Bleeding according to TIMI criteria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Kreutz, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612884
- Sponsor's protocol ID
- 1106005745
- Status last verified
- Mar 2018
- First submitted
- 4 Jun 2012
- Last updated
- 26 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
- ClinicalTrials.gov ID
- NCT01612884
- Acronym / sponsor ID
- 1106005745
- Conditions
- Thrombosis, Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Posted 26 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEG | Other | Drug: Prasugrel, Drug: ClopidogrelClopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69 |
| Light transmittance aggregometry | Other | Drug: Prasugrel, Drug: ClopidogrelClopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9% |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction) and referred for coronary angiography.
- Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for >5 days)
- Age range 21-75 years.
Key exclusion criteria (7 listed)
- Unable to give consent
- Age younger than 21 years, greater than 75 years
- History of stroke
- Body weight <60 kg
- Acute STEMI,
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 |
|---|---|---|
| PrasugrelPrasugrel 60mg loading dose at time of PCI if clopidogrel non-responder | Drug | Light transmittance aggregometry, TEG |
| ClopidogrelClopidogrel 300mg loading dose at time of PCI if clopidogrel responder | Drug | Light transmittance aggregometry, TEG |
Primary outcome
Thrombelastography (TEG) MA
Time frame: 1 day
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
2 secondary outcomes
Number of Participants With Ischemic Events
Time frame: 6 months
Number of Participants With Bleeding Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel and Clopidogrel in people with Thrombosis and Coronary Artery Disease, run by Indiana University at 2 sites 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 3 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: stopped early, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 26 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Thrombelastography (TEG) MA (time frame: 1 day). 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 26 Apr 2018.