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ekgcircle3.gif (1164 bytes) Summary of Relevant Clinical Studies
NOTE: Landmark Trials are those trials which are of substantive influence on the clinical practice of cardiovascular medicine.  Trials under the heading of Enrichment are to supplement information. As a student of Phar. 6122, you should be quite familiar with their Objectives, Methods, Results and Interpretation of those trials.  Additional trials are added which may augment the student's understanding of the area but may not have been as influential as others in contemporary practice.

Topic/Reference Status

html Version Description
Hypertension    
Landmark Trials for Hypertension
    pdf            html  Study Description 
ACCOMPLISH NA Benazepril plus Amlodipine or Hydrochlorothiazide for Hypertension in High-Risk Patients: the B-A combination was superior to B-HCT in reducing CV events in hypertensives at high risk for such events.
a.ASCOT-BPLA Article
b. ASCOT-BPLA editorial
NA (Blood pressure arm of ASCOT. Thearzede and β-blockers vs CCBA and ACE)
HYVET   Treatment of Hypertension in Patients 80 Yeasr of Age or Older: Treatment of the old-old, remains beneficial with diuretic with or without ACE inhibitor.

a. ON Target
b. ON Target Editorial

 

Telmisartan, Ramipril or Both in patients with high risk for vascular Events: Double blind randomized study with primary outcome of CV death, MI, Stroke or hospitalization for HF. Telmisartan equal to ramipril in pts with vascular disease or high risk diabetes but was associated with less angioedema. The combination was associated with more AE's without increase in benefit.

VALUE Trial

VALUE editorial

NA (valsartan vs. amlodipine for prompt blood pressure control)
Enrichment Trials for Hypertension
    pdf            html  Study Description 
a. AASK
b. article
c.
editorial
AASK Trial  (ISH, nitrendipine + others vs PL)
ABCD Trial ABCD Trial  (nisoldipine vs enalapril in preventing type 2 DM complications)
ANBP2 NA (Australia National Blood Pressure-2 Trial)
ALLHAT ALLHAT Trial  (chlorthalidone vs lisinopril, and amlodipine)
BENEDICT    
Blood Pressure Trialists' collaboration  

Effects of different blood-pressure-lowering regimens on major cardiovascular events

CAMELOT

NA  
DETAIL    
DREAM Trial NA Ramapril vs. Placebo in patients with either IFG or IGT but not diabetes for reduction in CV events
a. EUROPA Trial
b.
EUROPA Correspondence
a. NA
b. NA
(felodipine + ASA + goal BP)

Haffner Study

NA (Type 2 Diabetes and CV Risk)
a. HOPE ACE
b. Micro-HOPE
c. HOPE Vitamin E
d. HOPE Ambulatory vs. Office BP
a. HOPE ACE Trial
b. Micro-HOPE
c. HOPE Vitamin E Trial
d. NA
a. Ramapril vs. Placebo in High Risk Patients
b. HOPE for type 2 diabetics only
c. HOPE with Vitamin E component
d.
Comparative Effects of Ramipril on Ambulatory and Office Blood Pressures
HOT Trial HOT Trial   
IDNT IDNT Trial  (PL, irbesartan, amlodipine in type 2 DM nephropathy)
INVEST NA

A Calcium Antagonist vs a Non–Calcium Antagonist Hypertension Treatment Strategy for Patients With Coronary Artery Disease

IRMA II IRMA II Trial  (irbesartan in type 2 DM  + microalbuminuria)
a. LIFE
b. LIFE Trial Commentary
c. LIFE Trial Diabetes Patients

 
LIFE Trial 

(losartan vs. atenolol)

 

NA MIDAS Trial  (isradipine vs HCTZ in progression of mean max IMT)
NORDIL NA

Randomised trial of effects of calcium antagonists compared with diuretics and beta-blockers on cardiovascular morbidity and mortality in hypertension

a. PEACE Trial
b.
PEACE Editorial
a. NA
b. NA
a. 
b. 

PROGRESS

PROGRESS editorial

NA (peridndopril and indapamide to lower BP which had a larger risk reduction of recurrent stroke or TIA)
RENAAL Trial RENAAL Trial  (losartan in type 2 DM + nephropathy)

 

SHEP Stroke SHEP Trial  (captopril vs atenolol in type 2 DM)
Syst-China Trial SYST-China Trial  (doxazocin vs chlorthalidone)
Syst-Eur Trial SYST-EUR Trial  (ISH, nitrendipine + others vs PL)
NA TOMHS Trial  (ramipril vs amlodipine vs metoprolol in African Americans) (Management of High Blood Pressure in African Americans
UKPDS 39 Trial UKPDS 39 Trial  (chlorthalidone + atenolol in ISH)
B-Blocker meta-analysis NA Beta-blocker meta-analysis Lancet 2005
Lipids    
Landmark Trials for Lipids
    pdf            html  Study Description 

Enhance

NA

Simvastatin with or without Ezetimibe in Familial Hypercholesterolemia: In patients with FH, the addition of ezetimibe to simvastatin did not result in significant differences in the change in intima-media thickness vs. simvastatin alone.

FIELD Study

NA

Effects of long-term fenofibrate therapy on type 2 diabetes and CV events.

a. HPS
b. HPS Diabetes Substudy
c. HPS Antioxidant
HPS  (Simvastatin vs PL)

Jupiter

 

 

Rosuvastatin to prevent vascular events in men and women with elevated CRP: In this trial of apparently healthy people without hyperlipidemia but elevated hsCRP, rosuvastatin significantly reduced major CV events.
a. PROVE-IT
b. PROVE-IT Editorial
PROVE IT  (Atorvastatin 80 mg vs. Pravastatin 40 mg in ACS)
TNT Editorial NA Atorvastatin 10mg vs Atorvastatin in stable coronary disease
TNT Study NA The evaluation of intensive vs. moderate lipid lowering by statins for patients with chronic CAD (atorvastatin 80 vs. 10mg)
VA-HIT  VA-HIT  (gemfibrozil vs PL secondary prevention)
a. Grundy 2004 White Paper: Circulation  
b. Grundy 2005 Metabolic Syndrome
NA

NA

Proposed revision to NCEP ATP III guidelines -new targets
Diagnosis and Management of the Metabolic Syndrome
WOSCOPS  WOSCOPS  (Pravastatin primary Prevention)
Enrichment Trials for Lipids
    pdf            html  Study Description 
AFSCAPSTexCAPS AFSCAPS/TexCAPS  (Lovastatin primary Prevention)
ALLHAT-LLT  ALLHAT-LLT  (pravastatin vs usual care)
ASCOT-LLT   NA  (Lipid lowering arm. Atorvastatin 10 mg vs PL)
Phase Z of the A to Z trial   (Early Intensive vs. a Delayed Conservative Simvistatin Strategy in Patients With Acute Coronary Syndromes)
Asteroid Trial   (Effect of Very High-Intensity statin Therapy on Regression of Coronary Atherosclerosis)
BIP Trial BIP Study  (Benzfibrate secondary Prevention)
CARDS NA Atorvastatin 10mg vs. placebo in Type 2 diabetes.
4S Trial

4S Trial

4S 

(Simvastatin secondary Prevention)
a. CARE
b. CARE Diabetes
CARE  (Pravastatin primary Prevention)

a. IDEAL

b. IDEAL editorial

NA Comparison between High Dose Atorvastatin (80mg) vs. moderate dose Simvastatin (20mg) for secondary prevention of Coronary events
a. LIPID
b. LIPID Trial Follow-up
LIPID  (Pravastatin primary Prevention)
MIRACL  MIRACL  (atorvastatin vs post ACS)
Post Bypass Trial Post-Bypass Study  (Pravastatin secondary prevention)
PROSPER  PROSPER Trial  (Pravastatin in elderly CVD)
REVERSAL 

REVERSAL

(Atorvastatin 80 mg vs. Pravastatin 40 mg for coronary artery atheroma burden)
McKenny American Journal of Cardiology 2006 NLA Statin Safety Assesment NLA Statin Safety Assesment by McKenney et al. American Journal of Cardiology 2006; 97: 89-94

(Final Conclusions and Recommendations of the National Lipid Association Statin Safety Assessment Task Force)

Read both tables and recommendations

Anticoagulation  and Thrombolytic Studies 
Landmark Trials for Anticoagulation and Thrombolytic Studies

     pdf

         html

Study Description 
ASSENT-3 ASSENT-3  (TNK ase + Enoxaparin vs TNK + UFH, vs TNKase + abciximab + UFH)
NA

CAPRIE Trial

CAPRIE abstract

(clopedigrel vs ASA)
CREDO  NA Early combination therapy (Clopedigril + ALA with PCI)
CURE Trial  CURE Trial  (clopedigrel + ASA vs. ASA)
ESSENCE  ESSENCE  (Enoxaparin vs UFH)
GUSTO IV GUSTO IV  ACS (PL vs abciximab 24 hrs vs abciximab 48 hrs)

SYNERGY

SYNERGY editorial

  Enoxaparin vs. UFH in high-risk NSTEMI patients.
NA TIMI IIB  (enoxaprin vs UFH)
Enrichment Trails for Anticoagulation  and Thrombolytic Studies
    pdf            html  Study Description 
NA ASSENT-2  (SK vs t-PA over 3 hours)
Aspirin use in Women   Aspirin in Primary Prevention for Women
CLARITY-TIMI28 trial   Clopidogrel to Aspirin and Fibrinobtic Therapy for STEMI patient
CRUSADE STUDY NA  
NA EPILOG  (abciximab and low dose heparin vs PL w/standard dose heparin vs abciximab)
NA FRIC  (LMWH SC vs UFH)
NA FRISC II  (LMWH SC vs standard UFH)
NA GISSI-1  (St-PA vs. TNKase)
NA GISSI-2  (SK vs t-PA, APSAC)
NA GUSTO  (SK vs SK + ASA vs ASA vs Placebo)
GUSTO-III GUSTO-III  (SK vs Placebo)
NA GUSTO IIB  (angioplasty vs accelerated thrombolytic therapy)
GUSTO V

GUSTO V

 

AMI (retaplace vs 1/2 dose r-PA + abciximab)
NA ISIS-2  (SK vs t-PA over 3 hours)
NA ISIS-3  (SK + sq or IV hep vs t-PA over 90 minutes)
NA SPAF Trials  (stroke prevention w/ASA or warfarin in AF)

SPORTIF-V

SPORTIF-V editorial

NA Ximelagatran vs. Warfarin in patients with nonvalvular atrial fibrillation
NA TIMI-1  (r-PA vs Alteplase)
AMI Therapy    
Landmark Trials for AMI

   pdf

        html

Study Description

CAPRICORN CAPRICORN Carvedilol post AMI in patients with low EF
EPHESUS NA (eplerenone vs PL post AMI)
a. VALIANT
b.
VALIANT Editorial
NA Valsartan, captopril or both
Enrichment Trials for AMI
    pdf           html Study Description
NA Summary of ACE Inhibitors Post AMI Table of Studies with ACE inhibitors Post AMI
NA B-Blockers Meta analysis  B-blockers post AMI-meta analysis
NA  Summary of Beta-blockers Post AMI (Tables of beta-blockers Post MI) 
HART II Study  NA LMWH and Lytics with AMI
OPTIMAAL Trial OPTIMAAL Trial  Valsartan-captopril post MI
Antiarrhythmics    

Landmark Trial for Antiarrhythmics

    pdf            html  Study Description 
a. AFFIRM TRIAL
b. AFFIRM FOLLOW UP
AFFIRM Trial  (Rate control vs Rhythm control in AF patients)
ARREST TRIAL ARREST Trial  (amiodarone in cardiac arrest)
NA CAST and CAST II Trials I  (Flecainide, encainide, morcizine post MI)
Enrichment Trials for Antiarrhythmics
    pdf           html  Study Description 
NA Amiodarone Post Surgery   
NA AVID  (ICD vs amiodarone and sotalol in VAs)
NA CAMIAT  (amiodarone post MI)
Drug Induced QT Prolongation Review   (Roden NEJM 2004)
NA EMIAT  (amiodarone post MI)
NA ESVEM  (Sotalol and Holter Monitoring vs EPS)
LIFE -Trial-Afib analysis NA (LIFE trial analysis for endpoints of related to Afib. Angiotensin II Receptor Blockade Reduces New-Onsset Atrial Fibrillation and Subsequent Stroke Compared to Atenolol.)
NA MADIT  (ICD w/ventricular arrhythmias (VAs)
SCD HeFT Trial NA (conventional therapy and placebo vs. conventional therapy and amiodarone vs. convention therapy and ICD in HF patients with NYHA II or II and EF <35%)
NA Summary Table of Key Trials   
NA SWORD  (sotalol in post MI and LVD)
Congestive Heart Failure
Landmark Trials for Congestive Heart Failure
    pdf            html  Study Description 
a. CHARM Overall
b. CHARM Added
c. CHARM Alternative
d. CHARM Preserve
CHARM Series  Added, Overall, Preserved, Alleviate
COMET  NA (IR metoprolol vs. carvedilol in CHF)
COPERNICUS COPERNICUS  (cavedilol vs PL)
The DIG Study  The Dig Study  (Digoxin vs PL)
EPHESUS  NA (eplerenone vs PL post AMI)
MERIT-HF  MERIT-HF  (metroprolol CR-XL vs. PL)
RALES  RALES  (spironolactone vs. PL)
NA SOLVD  (enalapril vs PL)
Val-HEFT  Val-HEFT  valsartan vs standard therapy)
 VHeFT II VHeFT II  (enalapril vs hydralazine + ISDN in HF patients)
Enrichment Trials for Congestive Heart Failure
    pdf            html  Study Description 

 A-HeFT Trial

A-HefT editorial

NA (ISDN + hydralazine in African American NYHA III and IV HF patients)
ATLAS  ATLAS Trial  (Lisinopril high dose vs low dose)
Bisoprolol and Enalapril for CHF NA

Initiating Treatment for Chronic Heart Failure With Bisoprolol Followed by Enalapril, as Compared With the Opposite Sequence

NA

 

Carvedilol Studies in CHF

 

CIBIS-II Trial CIBIS- II  (bisoprolol vs PL)
NA CONSENSUS  (enalapril vs PL)
a. ELITE
b. ELITE II
ELITE  a. Losartan vs captopril in patients with HF where Losartan appeared to have benefits,
b. Losartan vs. captopril in HF patients where no difference existed
PRAISE  PRAISE  (amlodipine vs standard therapy)
Stains- Survival in HF NA  
VMAC NA IV Nesiritide vs. IV nitroglycerine for decompensated acute heart failure
Miscellaneous Studies    
Enrichment Trials for Miscellaneous Studies
    pdf            html  Study Description 
APC study   Study Description: CV risk with Celecoxib
Atrial Arrhythmia   Primer on Atrial Arrhythmia
Cardiac Art 1
Cardiac Art 2
Cardiac Art 3
Cardiac Art 4
Cardiac Art 5
Cardiac Art 6
  Primers on Cardiac function at cellular level
Cardiovascular effects and interactions with Herbals   Cardiovascular effects and interactions with Herbals
ECG Introduction    Primer on rhythm strip recognition and ECG information
ECG Terminology   Primer on ECG Terminology
  ESPS2   
Genomics 

 

  Antihypertensives
Inheritance and Drug Response   Genomics and Medicine NEJM 2003
Pharmacogenomics    - Drug Disposition, Drug Targets, and Side Effects
Tachycardis Part 1     Primer on Broad Complex Tachycardia Part 1
Tachycardias Part 2   Primer on Broad Complex Tachycardia Part 2
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