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The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).
Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)"on-treatment" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard therapy | Active Comparator | standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS) |
|
| individualized therapy | Experimental | dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prasugrel or ticagrelor | Drug | prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Definite Stent Thrombosis | The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis" | 30 days |
| Any Bleeding Event | Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL | 30days |
| Measure | Description | Time Frame |
|---|---|---|
| Probable Stent Thrombosis | Probable stent thrombosis is considered to have occurred in case of
| 30days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guenter Christ, MD | Kaiser Franz Josef Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Franz Josef Hospital | Vienna | State of Vienna | 1100 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19264241 | Background | Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030. | |
| 18387444 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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all consecutive PCI patients with stent implantation or drug eluting balloon dilation in our institution until June 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Therapy | standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS) |
| FG001 | Individualized Therapy | dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Therapy | standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS) |
| BG001 | Individualized Therapy | dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Definite Stent Thrombosis | The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis" | Posted | Number | participants | 30 days |
|
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it was not intended to collect adverse events, other than SAEs
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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 | Standard Therapy | standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Definite stentthrombosis | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Univ.Prof. Dr Günter Christ | Kaiser Franz Josef Hospital | +43160191 | 2508 | guenter.christ@wienkav.at |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Clopidogrel | Drug | clopidogrel 75mg od for 12 month |
|
|
| Bonello L, Camoin-Jau L, Arques S, Boyer C, Panagides D, Wittenberg O, Simeoni MC, Barragan P, Dignat-George F, Paganelli F. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiovascular events in patients with clopidogrel resistance: a multicenter randomized prospective study. J Am Coll Cardiol. 2008 Apr 8;51(14):1404-11. doi: 10.1016/j.jacc.2007.12.044. |
| 21406646 | Background | Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290. |
| 25361837 | Derived | Christ G, Siller-Matula JM, Francesconi M, Dechant C, Grohs K, Podczeck-Schweighofer A. Individualising dual antiplatelet therapy after percutaneous coronary intervention: the IDEAL-PCI registry. BMJ Open. 2014 Oct 31;4(10):e005781. doi: 10.1136/bmjopen-2014-005781. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Any Bleeding Event | Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL | Posted | Number | participants | 30days |
|
|
|
| Secondary | Probable Stent Thrombosis | Probable stent thrombosis is considered to have occurred in case of
| Posted | Number | participants | 30days |
|
|
|
| 26 |
| 664 |
| 0 |
| 0 |
| EG001 | Individualized Therapy | dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer | 18 | 343 | 0 | 0 |
| probable Stentthrombosis | Cardiac disorders | Systematic Assessment |
|
| Cardiovascular death | Cardiac disorders | Systematic Assessment |
|
| Bleeding (TIMI major) | Cardiac disorders | Systematic Assessment |
|
| Bleeding (TIMI minor) | Cardiac disorders | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |