Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis "AMTEC"

Terminated

Phase 4 Results N/A

Trial Description

The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.

Detailed Description

It is well known that risk of fatal and non-fatal stroke is increased in patients with significant carotid atherosclerosis. For asymptomatic patients, AHA guidelines recommend carotid endarterectomy (CEA) for stenosis 60% to 99%, if the risk of perioperative stroke or death is less than 3%.
Although clinical trial data support CEA in asymptomatic patients with carotid stenosis 60% to 79%, the AHA guidelines indicate that some physicians delay revascularization until there is greater than 80% stenosis in asymptomatic patients.
Our study is designed to determine whether optimal medical therapy alone reduces the risk of death and nonfatal stroke in patients with carotid artery stenosis as compared with CEA coupled with optimal medical therapy.

Trial Stopped: Due to the clear advantage of carotid endarterectomy

Conditions

Interventions

  • Atorvastatin (Lipitor®)Drug
    Other Names: Lipitor
    Intervention Desc: Competitive inhibitor of HMG-CoA reductase; lowers cholesterol and lipids
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • Carotid Endarterectomy Procedure
    Intervention Desc: CEA involves a neck incision and physical removal of the plaque from the inside of the artery
    ARM 1: Kind: Experimental
    Label: 1
    Description: Patients receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations. Additionally patients will undergo CEA.
    ARM 2: Kind: Experimental
    Label: CEA Group
    Description: Patients will undergo carotid endarterectomy (CEA) and receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.
  • Amlodipine Drug
    Intervention Desc: is a long-acting calcium channel blocker (dihydropyridine class) used as an anti-hypertensive and in the treatment of angina.
  • Losartan (Cozaar)Drug
    Other Names: losartan potassium; COZAAR®; MK0954
    Intervention Desc: is an angiotensin II receptor antagonist drug used mainly to treat high blood pressure (hypertension).
  • Atorvastatin, aspirin, losartan, amlodipine Drug
    Intervention Desc: aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day
    ARM 1: Kind: Experimental
    Label: 1
    Description: Patients receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations. Additionally patients will undergo CEA.
    ARM 2: Kind: Experimental
    Label: 2
    Description: Patients receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.
    ARM 3: Kind: Experimental
    Label: CEA Group
    Description: Patients will undergo carotid endarterectomy (CEA) and receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.
    ARM 4: Kind: Experimental
    Label: OMT Group
    Description: Patients will receive conservative therapy - optimal medical treatment (OMT) including statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of twos arms. In experimental arm patients receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations. Additionally patients will undergo CEA.In the Active Comparator patients receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations

Outcomes

Type Measure Time Frame Safety Issue
Primary Major adverse cardiovascular events (MACE: composite of stroke, myocardial infarction and cardiovascular death) and any death.
Secondary Restenosis after CEA.
Primary Major adverse cardiovascular events (MACE: composite of stroke, myocardial infarction and cardiovascular death) and any death 5 years Yes
Secondary Restenosis after CEA 5 years No
Primary composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death 5 years Yes
Secondary composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death 5 years No

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