CHOlesterol Lowering and Residual Risk in Type 2 Diabetes
Phase: PHASE4
Conditions: Type 2 Diabetes
Sponsor: NYU Langone Health

Official Title: 
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NCT Number
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Study Number: 
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Document Type:
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Date of the 
Document:
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1. 
Synopsis
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2. 
 Background and significance 
Diabetes and Cardiovascular Disease  
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3. 
 Specific Aims  
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4. 
Research Design 
4.1 
Recruitment 
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4.2 
Inclusion/Exclusion Criteria for Diabetes Patients 
 
Inclusion Criteria 
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1. $JH	
2. /'/&!PJGO
D 3UHYLRXVFOLQLFDOODEVZLOOEHXVHGIRUHOLJLELOLW\DVVHVVPHQWVFUHHQLQJ
3. $EOHDQGZLOOLQJWRSURYLGHZULWWHQLQIRUPHGFRQVHQWIRUWKHVWXG\
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,QGLYLGXDOVZLWKDQ/'/&!PJGOQRWHGDWDVVHVVPHQWVFUHHQLQJZKRVLJQFRQVHQWDQGWKHQDUHIRXQGWR
KDYHDQ/'/&PJGODWEDVHOLQHZLOOQRWEHH[FOXGHG
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Exclusion Criteria 
1. (VWDEOLVKHGFDUGLRYDVFXODUGLVHDVHRQDQWLWKURPERWLFWKHUDS\
2. 7ULJO\FHULGHV!PJGO
3. 8VHRID3&6.LQKLELWRU
4. 5HFHQWLQIHFWLRQLQWKHSDVWGD\V
5. $Q\KRVSLWDOL]DWLRQLQWKHSDVWGD\V
6. 8VHRI,PPXQRVXSSUHVVLYHWKHUDS\
7. 8VHRIDQ\DQWLWKURPERWLFWKHUDS\
8. 8VHRIDVSLULQ
9. 8VHRI16$,'ZLWKLQWKHSDVWKRXUV
10. 3UHJQDQF\
11. $QHPLDKHPRJORELQJGORUWKURPERF\WRSHQLD3ODWHOHWFRXQWRUWKURPERF\WRVLV3ODWHOHWFRXQW
!
12. .QRZQKHPRUUKDJLFGLDWKHVLV
13. &KURQLFNLGQH\GLVHDVH&U&OPOPLQ
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4.3 
Inclusion/Exclusion Criteria for Controls 
 
Inclusion Criteria
*URXS6XEMHFWVZLWKRXWNQRZQGLDEHWHV
1. $JH	 
2. Either: LDL-C >100mg/dl, or Lp(a) > 50 mg/dl
D 3UHYLRXVVFUHHQLQJODEVZLOOEHXVHGIRUHOLJLELOLW\DVVHVVPHQWVFUHHQLQJ
3. $EOHDQGZLOOLQJWRSURYLGHZULWWHQLQIRUPHGFRQVHQWIRUWKHVWXG\
 
,QGLYLGXDOVZLWKDQ/'/&!PJGOQRWHGDWDVVHVVPHQWVFUHHQLQJZKRVLJQFRQVHQWDQGWKHQDUHIRXQGWR
KDYHDQ/'/&PJGODWEDVHOLQHZLOOQRWEHH[FOXGHG
 
Exclusion Criteria
1. 'LDEHWHVW\SHRUW\SH
2. $OORWKHUH[FOXVLRQVDUHLGHQWLFDOWRWKHGLDEHWHVJURXS
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6XEMHFWVZLOOEHUHFUXLWHGIURPWKHRXWSDWLHQWJHQHUDOPHGLFLQHFDUGLRORJ\DQGHQGRFULQRORJ\FOLQLFVDW1<8
/DQJRQH+HDOWKLQFOXGLQJWKH0DQKDWWDQ%URRNO\QDQG/RQJ,VODQGFDPSXVHV:HZLOODOVRUHFUXLWIURPWKH
%HOOHYXH +RVSLWDO $GXOW &OLQLFV DQG LQSDWLHQW VHUYLFH DQG WKH 9$ KRVSLWDO 3DWLHQWV IXOILOOLQJ LQFOXVLRQ DQG
H[FOXVLRQFULWHULDLGHQWLILHGHLWKHUE\UHVHDUFKVWDIIZKRZLOOSUHVFUHHQVHOHFWFOLQLFVFKHGXOHVRUGLUHFWO\E\WKH
SDWLHQW¶VKHDOWKFDUHSURIHVVLRQDOZKRZLOOREWDLQYHUEDOFRQVHQWIRUFRQWDFWE\DPHPEHURIWKHUHVHDUFKVWDII

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4.4 
 Informed consent 
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ZLOOFRQGXFWWKHEDVHOLQHLQWHUYLHZZLWKWKHVXEMHFWDQGUHYLHZWKHFOLQLFDOKLVWRU\GHPRJUDSKLFLQIRUPDWLRQDQG
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LQFOXGLQJ GHSUHVVLRQ DQG VWUHVV DQG D SUHJQDQF\UHSURGXFWLYH TXHVWLRQQDLUH IRU IHPDOH SDUWLFLSDQWV 7KH
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4.5 
Methods 
4.5.1 Schedule of assessments 
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4.5.2 Longitudinal component 

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Table 1. 
Patient Group  
 
Baseline Visit 
Longitudinal 
Analysis 
Initial Follow-up Visit  
(at 4 weeks +/- 5 days) 
Second Follow-
up Visit (at 7-12 
weeks from 
baseline) 
*Optional* 
 
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6. BENEFITS 
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9. STATISTICAL ANALYSIS 
Specific Power Analysis: 
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10. DATA ANALYSIS 
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Statistical Analysis Plan for Platelet Activity Measurements 
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Statistical Analysis Plan for Platelet Transcriptomics 
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11. Safety and Adverse Events 
 
11.1 
Definitions 
 
Unanticipated Problems Involving Risk to Subjects or Others 
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Adverse Event 
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Serious Adverse Event 
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Adverse Event Reporting Period 
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Preexisting Condition 
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General Physical Examination Findings 
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Post-study Adverse Event 
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Abnormal Laboratory Values 
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Hospitalization, Prolonged Hospitalization or Surgery 
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11.2 Recording of Adverse Events 
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11.3 Reporting of Serious Adverse Events and Unanticipated Problems
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For Narrative Reports of Safety Events 
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11.3.1 Investigator reporting: notifying the study sponsor 
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Initial Report: within 24 hours: 
7KHIROORZLQJHYHQWVPXVWEHUHSRUWHGWRWKHVWXG\VSRQVRUE\WHOHSKRQHZLWKLQKRXUVRIDZDUHQHVVRIWKH
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Follow-up report: within 48 hours: 
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Other Reportable events: 
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Deviations from the study protocol 
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Bibliography  
 
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