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| ID | Type | Description | Link |
|---|---|---|---|
| 09-367 | |||
| 09-0421-F2L | |||
| 717/DG | |||
| AAAE0348 |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Sanofi | INDUSTRY |
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The purpose of this observational research study is to determine when and why patients discontinue, interrupt, or disrupt the regimen of anti-platelet medications prescribed following stent implantation, and to examine the relationship between specific patterns of non-adherence and patient outcomes.
Anti-platelet medicines are the cornerstone of therapy in patients who present with acute coronary syndromes, including unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI). Multiple clinical trials have demonstrated the efficacy of dual anti-platelet therapy (DAPT) for the prevention of thrombotic events in patients who present with unstable coronary symptoms; in particular, patients who are to receive percutaneous coronary intervention (PCI). Dual anti-platelet therapy consists of a combination of aspirin and a thienopyridine (such as clopidogrel or ticlopidine). While premature discontinuation (within the first 6 months) of such therapy is associated with an increased risk of stent thrombosis, the optimal duration of DAPT has not yet been precisely determined.
Although studies suggest an increased risk of stent thrombosis and adverse events within days after thienopyridine discontinuation, no study has collected detailed data as to the exact dates and reasons that anti-platelet agents were discontinued - thus, the true risks of premature early or even scheduled late discontinuation are unknown.
Furthermore, there are multiple modes that impact subject adherence to DAPT. These include non-compliance and cost issues.
We have determined three modes why subjects may not adhere to DAPT. These include:
These modes have not previously been systematically collected and correlated with adverse clinical events such as stent thrombosis. Furthermore, the relation of events to subsequent disruption of DAPT has not been studied prospectively. Subjects enrolled in this registry will be followed for approximately 24 months to determine the incidence of adherence according to the above classification. All patients will have their events and DAPT use monitored during the follow-up period. The assumption is that most subjects will discontinue their therapy voluntarily (usually according to their physician's advice) and that it is only those with disrupted therapy who are at risk for major adverse cardiac events (MACE). This registry will examine the predictors of DAPT disruption based on subject's demographics and determine the relationship of bleeding versus MI in these subjects using a time-dependent covariate adjusted analysis. Finally, since there are two completely different categories within the disrupted group, (non-compliance vs. event driven disruption), we will examine these patients separately as well, as a secondary endpoint.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Anti-platelet agent discontinuation/ interruption/ disruption | at 1 month | |
| Incidence of Anti-platelet agent discontinuation/ interruption/ disruption | at 6 months | |
| Incidence of Anti-platelet agent discontinuation/ interruption/ disruption | at 12 months | |
| Incidence of Anti-platelet agent discontinuation/ interruption/ disruption | at 24 months | |
| Incidence of major and minor bleeding (according to TIMI and ACUITY definitions) | at 1 month | |
| Incidence of major and minor bleeding (according to TIMI and ACUITY definitions) | at 6 months | |
| Incidence of major and minor bleeding (according to TIMI and ACUITY definitions) | at 12 months | |
| Incidence of major and minor bleeding (according to TIMI and ACUITY definitions) | at 24 months | |
| Incidence of definite and/or probable stent thrombosis (ARC definition) | at 1 month | |
| Incidence of definite and/or probable stent thrombosis (ARC definition) | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.) | at 1 month | |
| Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects in any of the participating US or European sites who have undergone successful stent implantation in a native coronary artery.
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| Name | Affiliation | Role |
|---|---|---|
| Roxana Mehran, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Antonio Colombo, MD | San Raffaele Hospital (Milan, Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Heart Center of Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30606052 | Derived | Baber U, Leisman DE, Cohen DJ, Gibson CM, Henry TD, Dangas G, Moliterno D, Kini A, Krucoff M, Colombo A, Chieffo A, Sartori S, Witzenbichler B, Steg PG, Pocock SJ, Mehran R. Tailoring Antiplatelet Therapy Intensity to Ischemic and Bleeding Risk. Circ Cardiovasc Qual Outcomes. 2019 Jan;12(1):e004945. doi: 10.1161/CIRCOUTCOMES.118.004945. | |
| 28916600 |
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| Incidence of definite and/or probable stent thrombosis (ARC definition) | at 12 months |
| Incidence of definite and/or probable stent thrombosis (ARC definition) | at 24 months |
| at 6 months |
| Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.) | at 12 months |
| Incidence of MACE. (MACE is defined as the composite of cardiac death, Q-wave myocardial infarction (MI), and unscheduled, ischemia driven revascularization of the target lesion.) | at 24 months |
| Incidence of NACE (NACE is defined as the composite of cardiac death, MI (Q and non-Q-wave), ischemia driven revascularization of the target lesion and major bleeding (ACUITY criteria).) | at 1 month |
| Incidence of NACE (NACE is defined as the composite of cardiac death, MI (Q and non-Q-wave), ischemia driven revascularization of the target lesion and major bleeding (ACUITY criteria).) | at 6 months |
| Incidence of NACE (NACE is defined as the composite of cardiac death, MI (Q and non-Q-wave), ischemia driven revascularization of the target lesion and major bleeding (ACUITY criteria).) | at 12 months |
| Incidence of NACE (NACE is defined as the composite of cardiac death, MI (Q and non-Q-wave), ischemia driven revascularization of the target lesion and major bleeding (ACUITY criteria).) | at 24 months |
| Indianapolis |
| Indiana |
| 46290 |
| United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Saint Luke's/ Mid-America Heart Institute | Kansas City | Missouri | 64111 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| Geisinger Medical Center Clinic | Danville | Pennsylvania | 17822 | United States |
| Hopital Bichat | Paris | 75877 | France |
| Charite - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Onassis Cardiac Surgery Center | Athens | 176 74 | Greece |
| Careggi Hospital | Florence | 50134 | Italy |
| San Raffaele Hospital | Milan | 20132 | Italy |
| Shah B, Baber U, Pocock SJ, Krucoff MW, Ariti C, Gibson CM, Steg PG, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Iakovou I, Dangas G, Aquino MB, Sartori S, Chieffo A, Moliterno DJ, Colombo A, Mehran R. White Blood Cell Count and Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention in the Contemporary Era: Insights From the PARIS Study (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients Registry). Circ Cardiovasc Interv. 2017 Sep;10(9):e004981. doi: 10.1161/CIRCINTERVENTIONS.117.004981. |
| 27079334 | Derived | Baber U, Mehran R, Giustino G, Cohen DJ, Henry TD, Sartori S, Ariti C, Litherland C, Dangas G, Gibson CM, Krucoff MW, Moliterno DJ, Kirtane AJ, Stone GW, Colombo A, Chieffo A, Kini AS, Witzenbichler B, Weisz G, Steg PG, Pocock S. Coronary Thrombosis and Major Bleeding After PCI With Drug-Eluting Stents: Risk Scores From PARIS. J Am Coll Cardiol. 2016 May 17;67(19):2224-2234. doi: 10.1016/j.jacc.2016.02.064. Epub 2016 Apr 11. |
| 24004642 | Derived | Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Berger PB, Iakovou I, Dangas G, Waksman R, Antoniucci D, Sartori S, Krucoff MW, Hermiller JB, Shawl F, Gibson CM, Chieffo A, Alu M, Moliterno DJ, Colombo A, Pocock S. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet. 2013 Nov 23;382(9906):1714-22. doi: 10.1016/S0140-6736(13)61720-1. Epub 2013 Sep 1. |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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