Clinical trial NCT00655473: A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
Official title: A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* CHD, including patients with other CHD risk factors;
* treated appropriately for dyslipidemia;
* clinically stable.

Exclusion Criteria:

* previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
* recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
* severe anemia;
* uncontrolled hypertension;
* poorly controlled diabetes.

Primary outcomes:
measure: Percent Change From Baseline in Mean Wall Thickness
timeFrame: 24 months
measure: Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
timeFrame: 6 months
measure: Change From Baseline in Vessel MR Determined Plaque Anatomy
timeFrame: Up to 24 months
measure: Blood Lipids,Lipoproteins
timeFrame: Throughout study
measure: Biomarkers
timeFrame: Up to 24 months
measure: CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
timeFrame: Throughout study
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Royal Oak
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Duivenvoorden R, Mani V, Woodward M, Kallend D, Suchankova G, Fuster V, Rudd JHF, Tawakol A, Farkouh ME, Fayad ZA. Relationship of serum inflammatory biomarkers with plaque inflammation assessed by FDG PET/CT: the dal-PLAQUE study. JACC Cardiovasc Imaging. 2013 Oct;6(10):1087-1094. doi: 10.1016/j.jcmg.2013.03.009.
citation: Calcagno C, Ramachandran S, Izquierdo-Garcia D, Mani V, Millon A, Rosenbaum D, Tawakol A, Woodward M, Bucerius J, Moshier E, Godbold J, Kallend D, Farkouh ME, Fuster V, Rudd JH, Fayad ZA. The complementary roles of dynamic contrast-enhanced MRI and 18F-fluorodeoxyglucose PET/CT for imaging of carotid atherosclerosis. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1884-93. doi: 10.1007/s00259-013-2518-4. Epub 2013 Aug 14.
citation: Fayad ZA, Mani V, Woodward M, Kallend D, Abt M, Burgess T, Fuster V, Ballantyne CM, Stein EA, Tardif JC, Rudd JH, Farkouh ME, Tawakol A; dal-PLAQUE Investigators. Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial. Lancet. 2011 Oct 29;378(9802):1547-59. doi: 10.1016/S0140-6736(11)61383-4. Epub 2011 Sep 9.