Hello Jpalmerlaw,
Clinicaltrials.gov provides the Inclusion and Exclusion Criteria for
the study ?SEARCH: Study of the Effectiveness of Additional Reductions
in Cholesterol and Homocysteine.?
Eligibility
Ages Eligible for Study: 18 Years - 80 Years,
Genders Eligible for Study: Both
Criteria
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Inclusion Criteria
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Prior myocardial infarction
Statin therapy indicated
No clear indication for folic acid
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Exclusion Criteria
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No clear contraindication to study treatments
Screening plasma total cholesterol <3.5 mmol/l in patient already on
statin therapy, or <4.5 mmol/l in patient not on statin therapy
Chronic liver disease
Severe renal disease or evidence of renal impairment
Inflammatory muscle disease
Concurrent treatment with fibrates or high-dose niacin
Concurrent treatment with cyclosporin (or condition likely to result
in organ transplantation and the need for cyclosporin), nefazodone,
methotrexate, systemic azole antifungal or systemic macrolide
antibiotics
Child bearing potential
No other predominant medical problem (other than coronary heart
disease [CHD]) which might limit compliance with 5 years of study
treatment
Study ID Numbers: CTSUSEARCH1
Last Updated: December 8, 2005
Record first received: July 22, 2005
ClinicalTrials.gov Identifier: NCT00124072
Health Authority: United Kingdom: Medicines and Healthcare Products
Regulatory Agency
Source: Clincaltrials.gov
http://www.clinicaltrials.gov/ct/show/NCT00124072;jsessionid=9B310E3CBA8DA0AE1598A7B7E0A304E2?order=3
Location Information
CTSU
Richard Doll Building
Old Road Campus
Roosevelt Drive
Oxford
OX3 7LF
United Kingdom.
Tel: +44 1865 743743
Fax: +44 1865 743985
http://www.ctsu.ox.ac.uk/projects/search.shtml
From Controlled Trials:
Study of the Effectiveness of Additional Reductions in Cholesterol and
Homocysteine SEARCH
Participants - inclusion criteria
Men and women who have survivied a heart attack and in whom statin
therapy is indicated.
Participants - exclusion criteria
Age under 18 years or over 80 at invitation, contraindications to
either study drug, other predominant medical problem
Email Secretary@ctsu.ox.ac.uk
Sponsor University of Oxford (UK)
Tel +44 (0)1865 270000
Fax +44 (0)1865 270708
Email search@ctsu.ox.ac.uk
Sponsor website http://www.ox.ac.uk
Source: Controlled Trials
http://www.controlled-trials.com/isrctn/trial/%7C/0/74348595.html
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Additional information that might interest you
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There was a pilot study with simvastatin and folic acid/vitamin B12 in
preparation for the Study of the Effectiveness of Additional
Reductions in Cholesterol and Homocysteine (SEARCH).
?This study was conducted in preparation for the Study Evaluating
Additional Reduction in Cholesterol and Homocysteine (SEARCH).
Read the abstract here: Medline
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=11079257&dopt=Abstract
Inclusions and Exclusions
?Eligible patients were aged between 18-70 and had LDLC greater than
3.5 mmol/L (135 mg/dL) and triglycerides ?3.95 mmol/L (350 mg/dL) at
the time of screening.
Principal trial exclusion criteria were a diagnosis of Types I, III,
IV, V hyperlipidaemias; homozygous familial hypercholesterolaemia or
partial ileal bypass; MI, percutaneous transluminal coronary
angioplasty or coronary bypass surgery within the previous 6 months;
acute coronary insufficiency; vasospastic (Prinzmetal) angina;
uncontrolled hypertension (treated or untreated) with systolic blood
pressure >160 mmHg or diastolic >100 mmHg; secondary
hypercholesterolaemia due to nephrotic syndrome or hypothyroidism, but
patients with a history of hypothyroidism who were on a stable dose of
thyroxine with normalized plasma thyroxine and thyroid stimulating
hormone (TSH) were included. Patients with known diabetes mellitas
were excluded if haemoglobinA1c was ?10% at screening. Patients with
active liver disease or with elevated liver transaminases (10% above
the Upper Limit Normal, ULN)
or creatine kinase (CK) >50% above the ULN without obvious aetiology
were also excluded. Patients with renal insufficiency [serum
creatinine >179 ?mol/L (1.8 mg/dL)]or vitamin B12 deficiency (less
than 148 pmol/L or less than 200 pg/mL) were also excluded.?
A pilot study with simvastatin and folic acid/vitamin B12 in
preparation for the study of the effectiveness of additional
reductions in cholesterol and homocysteine (SEARCH).
MacMahon M, Kirkpatrick C, Cummings CE, et al.
Nutr Metab Cardiovasc Dis. 2000;10:195?203.
Download here:
http://www.oxiline.com.br/oxiline/download/sinva-folico-b12.pdf
Search criteria:
SEARCH ?Study of the Effectiveness of Additional Reductions in
Cholesterol and Homocysteine?
Exclusion OR exclusions
Patients criteria
I hope the information provided is helpful!
Best regards,
Bobbie7 |
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