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The objective of the present study was to evaluate the prognostic impact of prolonged dual antiplatelet therapy (DAPT) with acetylsalicylic acid plus clopidogrel on the incidence of major adverse cardiovascular events and major adverse limb events after percutaneous lower extremity revascularization in patients with lower extremity peripheral arterial disease (LE-PAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short DAPT | Experimental | Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months |
|
| Long DAPT | Experimental | Patients who will be treated after PTA with acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short DAPT | Drug | acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Cardiovascular Events + incidence of Major Adverse Limb Events | Impact of prolonged vs. short dual antiplatelet therapy after PTA on the incidence of major adverse cardiovascular events (death from cardiovascular cause, myocardial infarction, stroke, coronary or carotid revascularization) + the incidence of major adverse limb events (restenosis, occlusion, or new revascularization of target lesion, new stenosis, occlusion, or revascularization of not-target lesion, onset of acute and critical limb ischemia, amputation). | 24 months post-PTA |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of minor and major bleedings according to the GUSTO classification | Incidence of minor and major bleedings according to the Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries classification | 24 months post-PTA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Giugliano, MD, PhD | Contact | 00390817462240 | giuseppe.giugliano@unina.it | |
| Giovanni Esposito, MD, PhD | Contact | 00390817463075 | espogiov@unina.it |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Trimarco | Federico II University | Study Director |
| Giovanni Esposito, MD, PhD | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Advanced Biomedical Sciences, University of Naples "Federico II" | Recruiting | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11786451 | Background | Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71. | |
| 8918275 | Background | CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996 Nov 16;348(9038):1329-39. doi: 10.1016/s0140-6736(96)09457-3. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Long DAPT | Drug | acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months |
|
|
| 12719196 | Background | Belch JJ, Topol EJ, Agnelli G, Bertrand M, Califf RM, Clement DL, Creager MA, Easton JD, Gavin JR 3rd, Greenland P, Hankey G, Hanrath P, Hirsch AT, Meyer J, Smith SC, Sullivan F, Weber MA; Prevention of Atherothrombotic Disease Network. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med. 2003 Apr 28;163(8):884-92. doi: 10.1001/archinte.163.8.884. No abstract available. |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |