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| Name | Class |
|---|---|
| Medtronic Vascular | INDUSTRY |
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For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Arm- Medical therapy | Other | Medical therapy |
|
| Invasive Arm-angiogram with PCI or CABG | Other | same medical drug therapy as conservative arm, and angiogram with PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting) revascularisation if appropriate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative Arm | Drug | crossover to angiogram only if predefined criteria met |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death | The cause of death will be adjudicated as being due to cardiovascular causes, non cardiovascular causes, or undetermined causes.
N.B For this trial all deaths with undetermined causes will be included in the cardiovascular category. | 1 year |
| non-fatal myocardial infarction | The ESC/ACC (European Society of Cardiology and the American College of Cardiology) definition of myocardial infarction will be applied, including the special circumstances of same admission myocardial re-infarction, or myocardial infarction peri-PCI. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned revascularisation | Shall be deemed to have occurred at follow-up if any coronary vessel requires or undergoes attempted repeat revascularisation with either balloon angioplasty, stenting, or coronary artery bypass grafting. | 1 years |
| Permanent Stroke |
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Inclusion Criteria:
Suitable for conservative or invasive strategy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000319 | Adrenergic beta-Antagonists |
| D017298 | Bisoprolol |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Invasive Arm | Procedure | angiogram with PCI or CABG revascularisation if appropriate |
|
A stroke is a loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset or leading to death |
| 1 year |
| Major bleeding | BARC (Bleeding Academic Research Consortium) definition | 1 year |
| Deterioration of renal function during hospital admission | Worsening renal function is an absolute increase in serum creatinine of ≥ 0.3mg/dl (26.5 umol/l) at any time during hospitalization compared to the valve obtained at admission | During index admission |
| Angina symptoms (3 months; 1yr) | CCS (Canadian Cardiovascular Society Classification of angina) grading of angina | 3 months and 1 year |
| Stent thrombosis | ARC definition of stent Thrombosis | 1 year |
| All cause mortality | Cardiac and non cardiac mortality | 2,3 and 4 year |
| Hospital readmission for ACS/STEMI | ESC/ACC definition ACS/STEMI (Acute coronary syndrome/ST-segment elevation myocardial infarction) | At 3, 6 and 12 months and at 2,3 and 4 years |
| In-hospital major complications | In hospital major complications defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke. | At 3, 6 and 12 months and at 2,3 and 4 |
| D012459 |
| Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |