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Slow enrollment
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEG | Other | Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69 |
|
| Light transmittance aggregometry | Other | Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombelastography (TEG) MA | Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ischemic Events | Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention | 6 months |
| Number of Participants With Bleeding Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Health Methodist Hospital |
67 subjects were enrolled and underwent testing on day 0. Only 37 of those subjects underwent PCI, and therefore were randomized to either LTA or TEG guided intervention arm. The remainder of subjects were treated medically without PCI or were referred for CABG (see flow diagram in protocol) and did not get randomized to any intervention arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Thrombelastography (TEG) Guided | Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder |
| FG001 | Light Transmittance Aggregometry Guided | Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thrombelastography (TEG) Guided | Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thrombelastography (TEG) MA | Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel | TEG-MA (mm) at 16-24 hours outcome measure | Posted | Mean | Standard Deviation | mm | 1 day |
|
Complete duration of study period (6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thrombelastography (TEG) Guided | Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69 Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rolf Kreutz, MD | Indiana University School of Medicine | 3179620500 | rkreutz@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2011 | Feb 27, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2011 | Mar 28, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Clopidogrel | Drug | Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder |
|
Major or Minor Bleeding according to TIMI criteria
| 6 months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Light Transmittance Aggregometry Guided |
Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| Secondary | Number of Participants With Ischemic Events | Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention | Posted | Count of Participants | Participants | 6 months |
|
|
|
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| Secondary | Number of Participants With Bleeding Events | Major or Minor Bleeding according to TIMI criteria | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Light Transmittance Aggregometry Guided | Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9% Prasugrel: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder Clopidogrel: Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder | 0 | 18 | 0 | 18 | 0 | 18 |
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| D017202 |
| Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Myocardial Infarction |
|
| Recurrent coronary intervention |
|
| Unstable Angina |
|