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Patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention.
The aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reload | Experimental | 600 mg of clopidogrel loading dose 6-8 h before coronary angiogram, in addition to the chronic daily dose of 75 mg |
|
| Placebo | Placebo Comparator | Placebo arm in addition to the chronic daily dose of 75 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | 600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events | Death Myocardial Infarction Target Vessel Revascularization | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Events | Occurrence of vascular/bleeding complications, defined as: (a) major bleeding (intracranial bleeding or clinically overt bleeding associated with a decrease in haemoglobin >5 g/dL, according to the TIMI criteria); (b) minor bleeding (clinically overt haemorrhage associated with a fall in haemoglobin ≤5 g/dL); (c) entry-site complications (haematoma >5 cm, pseudoaneurysm or arteriovenous fistula) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Patti, MD | Contact | 06225411899 | g.patti@unicampus.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Patti, MD | Campus Bio-Medico University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vito Fazzi Hospital | Recruiting | Lecce | Lecce | 73100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20363764 | Background | Di Sciascio G, Patti G, Pasceri V, Colonna G, Mangiacapra F, Montinaro A; ARMYDA-4 RELOAD Investigators. Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial. Eur Heart J. 2010 Jun;31(11):1337-43. doi: 10.1093/eurheartj/ehq081. Epub 2010 Apr 2. | |
| 15262828 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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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| Placebo | Drug | Placebo in addition to the chronic daily dose of 75 mg |
|
| 30 days |
| Grade of platelet residual reactivity | Patient's response to clopidogrel at 3 different timing, assessed with VerifyNow P2Y12 Assays. The first timing is immediately before PCI (4-6h after randomization), once accomplished the diagnostic angiogram. The second and third timings are, respectively, 8h and 24h after PCI. | Immediately before PCI (4-6h after randomization), 8h and 24h after PCI |
| Campus Bio-Medico University | Recruiting | Rome | Rome | 00128 | Italy |
|
| Background |
| Kastrati A, von Beckerath N, Joost A, Pogatsa-Murray G, Gorchakova O, Schomig A. Loading with 600 mg clopidogrel in patients with coronary artery disease with and without chronic clopidogrel therapy. Circulation. 2004 Oct 5;110(14):1916-9. doi: 10.1161/01.CIR.0000137972.74120.12. Epub 2004 Jul 19. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |