A Study of the Effect of Dalcetrapib on Artherosclerotic Disease in Patients With Coronary Artery Disease

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01059682
• Collaborator: (none)
• Enrollment: 936
• Locations: 110
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This multicenter, double-blind, randomized, placebo-controlled study will evaluate the effect of dalcetrapib 600 mg on artherosclerotic disease progression, lipid profile and biomarker profile and long-term safety profile of dalcetrapib in patients with coronary artery disease. Atherosclerotic disease progression will be measured 1. Coronary Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography 2. Carotid B-Mode Ultrasound Intima Medial Thickness (IMT) and total plaque volume in subjects undergoing coronary angiography who have coronary artery disease (CAD). Patients will be randomized to receive dalcetrapib 600 mg orally once a day or placebo. The anticipated time on study treatment will be 24 months. The target sample size is 800-1000 patients.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Dalcetrapib; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 936 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-blind, Randomized, Placebo Controlled, Parallel Group Study of the Effect of Dalcetrapib on Atherosclerotic Disease Progression As Measured by Coronary Intravascular Ultrasound, Carotid B-Mode Ultrasound and Coronary Angiography
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dalcetrapib	Drug: Dalcetrapib; Dalcetrapib 600 mg orally once daily
Placebo Comparator: Placebo	Drug: Placebo; Placebo orally once daily

Outcome Measures

Primary Outcome Measures

1. Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS. [24 months]

2. Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound [24 months]

Secondary Outcome Measures

1. Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography [24 months]

2. Blood Lipids, Lipoproteins [Throughout study, 24 months]

3. Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography [Throughout Study, 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients over the age of 18 years

• Angiographic evidence of coronary artery disease

• Ultrasound evidence of carotid artery disease

• Treated appropriately for dyslipidemia

Exclusion Criteria:

• Previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or CETP-vaccine within the last 3 months before study start

• Previous coronary artery bypass graft surgery (CABG) or probable need for CABG in the next 24 months

• Myocardial infarction in the target coronary artery for IVUS between the initial IVUS examination and randomization

• Patients who have symptomatic congestive heart failure at baseline (New York Heart Association class III or IV)

• Severe anemia

• Uncontrolled hypertension

• Poorly controlled diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States	90033
2		Los Angeles	California	United States	90073
3		Torrance	California	United States	90502
4		Boulder	Colorado	United States	80304
5		Greeley	Colorado	United States	80631
6		Littleton	Colorado	United States	80120
7		Hartford	Connecticut	United States	06115
8		Atlantis	Florida	United States	33462
9		Fort Lauderdale	Florida	United States	33308
10		Fort Lauderdale	Florida	United States	33316
11		Jacksonville	Florida	United States	32216
12		Miami	Florida	United States	33137
13		Sarasota	Florida	United States	34239
14		Tampa	Florida	United States	33609
15		Decatur	Georgia	United States	30033
16		Chicago	Illinois	United States	60637-1470
17		Elkhart	Indiana	United States	46514
18		Louisville	Kentucky	United States	40205
19		Columbia	Maryland	United States	21044
20		Salisbury	Maryland	United States	21804
21		Boston	Massachusetts	United States	02114
22		Ann Arbor	Michigan	United States	48109-0666
23		Kalamazoo	Michigan	United States	49048
24		Midland	Michigan	United States	48670
25		Muskegon	Michigan	United States	49444
26		Petoskey	Michigan	United States	49770
27		Duluth	Minnesota	United States	55805
28		Rochester	Minnesota	United States	55905
29		Kansas City	Missouri	United States	64114
30		Paramus	New Jersey	United States	07652
31		New York	New York	United States	10011
32		Rochester	New York	United States	14642
33		Chapel Hill	North Carolina	United States	27599
34		Toledo	Ohio	United States	43614
35		Hershey	Pennsylvania	United States	17033
36		Providence	Rhode Island	United States	02906
37		Germantown	Tennessee	United States	38138
38		Oak Ridge	Tennessee	United States	37830
39		Dallas	Texas	United States	75216
40		Houston	Texas	United States	77030
41		Richmond	Virginia	United States	23249
42		Calgary	Alberta	Canada	T2N 2T9
43		Edmonton	Alberta	Canada	T5H 3V9
44		Edmonton	Alberta	Canada	T6G1Z1
45		Edmonton	Alberta	Canada	V6Z 1Y6
46		New Westminster	British Columbia	Canada	V3L 3W4
47		Vancouver	British Columbia	Canada	V5Z 1L8
48		Victoria	British Columbia	Canada	V8R 4Z3
49		Saint John	New Brunswick	Canada	E2L 4L2
50		St. John's	Newfoundland and Labrador	Canada	A1B 3V6
51		Halifax	Nova Scotia	Canada	B3H 3A7
52		Brampton	Ontario	Canada	L6Z 4N5
53		Burlington	Ontario	Canada	L7M 4Y1
54		Cambridge	Ontario	Canada	N1R 6V6
55		Hamilton	Ontario	Canada	L8L 2X2
56		Kitchener	Ontario	Canada	N2M 5N4
57		London	Ontario	Canada	N6A 5A5
58		Mississauga	Ontario	Canada	L5K 2L3
59		Newmarket	Ontario	Canada	L3Y 2R2
60		Oshawa	Ontario	Canada	L1J 2J9
61		Ottawa	Ontario	Canada	K1Y 4W7
62		Scarborough	Ontario	Canada	M1E 4B9
63		Toronto	Ontario	Canada	M4N 3M5
64		Toronto	Ontario	Canada	M5B 1W8
65		Toronto	Ontario	Canada	M5G 1L7
66		Chicoutimi	Quebec	Canada	G7H 5H6
67		Fleurimont	Quebec	Canada	J1H 5N4
68		Gatineau	Quebec	Canada	J8Y 6S9
69		Greenfield Park	Quebec	Canada	J4V 2G8
70		Lachine	Quebec	Canada	H8S 2E4
71		Laval	Quebec	Canada	H7M 3L9
72		Montreal	Quebec	Canada	H1T 1C8
73		Montreal	Quebec	Canada	H3G 1A4
74		Montreal	Quebec	Canada	H4J 1C5
75		Montréal	Quebec	Canada	H2W 1T8
76		Montréal	Quebec	Canada	H3J 2V5
77		Saint Georges-de-beauce	Quebec	Canada	G5Y 4T8
78		St-Charles-Borromée	Quebec	Canada	J6E 6J2
79		St-jerome	Quebec	Canada	J7Z 5T3
80		St-Lambert	Quebec	Canada	J4P 2H4
81		Ste. Foy	Quebec	Canada	G1V 4G5
82		Sudbury	Quebec	Canada	P3E 3Y9
83		Trois-Rivieres	Quebec	Canada	G8Z 3R9
84		Val D'or	Quebec	Canada	J9P 3Y1
85		Saskatoon	Saskatchewan	Canada	S7N 0W8
86		Aachen		Germany	52074
87		Berlin		Germany	12203
88		Darmstadt		Germany	64283
89		Essen		Germany	45138
90		Hamburg		Germany	20099
91		Hamburg		Germany	22527
92		Heidelberg		Germany	69120
93		Leipzig		Germany	04289
94		Muenchen		Germany	80336
95		München		Germany	81737
96		Regensburg		Germany	93053
97		Ulm		Germany	89081
98		Elblag		Poland	82-300
99		Gdańsk		Poland	80- 952
100		Krakow		Poland	31-202
101		Kraków		Poland	31-501
102		Lublin		Poland	20- 954
103		Poznan		Poland	61-848
104		Warszawa		Poland	01- 141
105		Warszawa		Poland	02-507
106		Warszawa		Poland	04-628
107		Wroclaw		Poland	50-981
108		Geneve		Switzerland	1211
109		Kreuzlingen		Switzerland	8280
110		Zürich		Switzerland	8091

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01059682
• Other Study ID Numbers: NC22703
• First Posted: Feb 1, 2010
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Cardiovascular Diseases; Dalcetrapib

Study Results

Participant Flow

Arm/Group Title	Dalcetrapib	Placebo
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily	Placebo: Placebo orally once daily
Period Title: Overall Study
STARTED	474	462
COMPLETED	464	444
NOT COMPLETED	10	18

Baseline Characteristics

Arm/Group Title	Dalcetrapib	Placebo	Total
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily	Placebo: Placebo orally once daily	Total of all reporting groups
Overall Participants	474	462	936
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.5 (8.48)	60.4 (8.86)	60.5 (8.66)
Sex: Female, Male (Count of Participants)
Female	127 26.8%	108 23.4%	235 25.1%
Male	347 73.2%	354 76.6%	701 74.9%

Outcome Measures

1. Primary Outcome

Title	Nominal Change From Baseline to Study End in Coronary Percent Atheroma Volume (PAV) of the Target Coronary Artery Assessed by IVUS.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dalcetrapib	Placebo
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily	Placebo: Placebo orally once daily
Measure Participants	474	462
Mean (Standard Deviation) [Percent Change Atheroma Volume]	0.6 (3.69)	0.5 (2.01)

2. Primary Outcome

Title	Rate of Change From Baseline to Study End in Carotid Intima-media Thickness (CIMT) Using B-mode Ultrasound
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dalcetrapib	Placebo
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily	Placebo: Placebo orally once daily
Measure Participants	363	356
Mean (Standard Deviation) [mm/year]	0.003 (0.0588)	0.003 (0.0568)

3. Secondary Outcome

Title	Nominal Changes From Baseline in Minimal Lumen Diameter as Assessed by Quantitative Coronary Angiography
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dalcetrapib	Placebo
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily	Placebo: Placebo orally once daily
Measure Participants	474	462
Mean (Standard Deviation) [mm]	-0.1 (0.18)	0.0 (0.10)

4. Secondary Outcome

Title	Blood Lipids, Lipoproteins
Time Frame	Throughout study, 24 months

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Dalcetrapib	Placebo
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily	Placebo: Placebo orally once daily
Measure Participants	0	0

5. Secondary Outcome

Title	Nominal Changes in Percent Diameter Stenosis as Assessed by Quantitative Coronary Angiography
Time Frame	Throughout Study, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dalcetrapib	Placebo
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily	Placebo: Placebo orally once daily
Measure Participants	474	462
Mean (Standard Deviation) [Percent Diameter Stenosis]	9.2 (20.65)	4.3 (14.36)

Adverse Events

Arm/Group Title	Dalcetrapib		Placebo
Arm/Group Description	Dalcetrapib: Dalcetrapib 600 mg orally once daily		Placebo: Placebo orally once daily
All Cause Mortality
	Dalcetrapib		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dalcetrapib		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/474 (12.9%)		63/462 (13.6%)
Blood and lymphatic system disorders
Anaemia	1/474 (0.2%)		0/462 (0%)
Idiopathic Thrombocytopenia Purpura	0/474 (0%)		1/462 (0.2%)
Thrombocytopenia	0/474 (0%)		1/462 (0.2%)
Cardiac disorders
Angina Pectoris	5/474 (1.1%)		3/462 (0.6%)
Angina Unstable	2/474 (0.4%)		3/462 (0.6%)
Atrial Fibrillation	3/474 (0.6%)		1/462 (0.2%)
Cardiac Failure Congestive	1/474 (0.2%)		1/462 (0.2%)
Prinzmetal Angina	0/474 (0%)		2/462 (0.4%)
Sick Sinus Syndrome	1/474 (0.2%)		1/462 (0.2%)
Atrial Flutter	0/474 (0%)		1/462 (0.2%)
Atrioventricular Block Complete	0/474 (0%)		1/462 (0.2%)
Atrioventricular Block Second Degree	0/474 (0%)		1/462 (0.2%)
Bradycardia	0/474 (0%)		1/462 (0.2%)
Sinus Bradycardia	1/474 (0.2%)		0/462 (0%)
Ventricular Extrasystoles	0/474 (0%)		1/462 (0.2%)
Ventricular Tachicardia	0/474 (0%)		1/462 (0.2%)
Endocrine disorders
Hyperthyroidism	1/474 (0.2%)		0/462 (0%)
Gastrointestinal disorders
Pancreatitis	1/474 (0.2%)		3/462 (0.6%)
Abdominal Pain	0/474 (0%)		1/462 (0.2%)
Crohn's Disease	1/474 (0.2%)		0/462 (0%)
Diarrhea Hemorrhagic	0/474 (0%)		1/462 (0.2%)
Dyspepsia	1/474 (0.2%)		0/462 (0%)
Hiatus Hernia	1/474 (0.2%)		0/462 (0%)
Rectal Hemorrhage	1/474 (0.2%)		0/462 (0%)
General disorders
Chest Pain	3/474 (0.6%)		7/462 (1.5%)
Non-Cardiac Chest Pain	1/474 (0.2%)		2/462 (0.4%)
Chest Discomfort	2/474 (0.4%)		0/462 (0%)
Device Failure	0/474 (0%)		1/462 (0.2%)
Medical Device Complication	0/474 (0%)		1/462 (0.2%)
Pyrexia	0/474 (0%)		1/462 (0.2%)
Hepatobiliary disorders
Bile Duct Stone	0/474 (0%)		2/462 (0.4%)
Cholangitis	0/474 (0%)		1/462 (0.2%)
Cholecystitis	1/474 (0.2%)		0/462 (0%)
Cholecystitis Acute	0/474 (0%)		1/462 (0.2%)
Hepatic Cirrhosis	0/474 (0%)		1/462 (0.2%)
Infections and infestations
Pneumonia	3/474 (0.6%)		2/462 (0.4%)
Clostridial Infection	1/474 (0.2%)		0/462 (0%)
Cystitis	0/474 (0%)		1/462 (0.2%)
Diverticulitis	0/474 (0%)		1/462 (0.2%)
Tonsillitis	0/474 (0%)		1/462 (0.2%)
Urosepsis	0/474 (0%)		1/462 (0.2%)
Wound Infection	0/474 (0%)		1/462 (0.2%)
Injury, poisoning and procedural complications
Arterial Injury	0/474 (0%)		1/462 (0.2%)
Foot Fracture	1/474 (0.2%)		0/462 (0%)
Joint Dislocation	0/474 (0%)		1/462 (0.2%)
Limb Traumatic Amputaton	0/474 (0%)		1/462 (0.2%)
Post Procedural Hemorrhage	1/474 (0.2%)		0/462 (0%)
Post Procedural Pulmonary Embolism	1/474 (0.2%)		0/462 (0%)
Wrist Fracture	1/474 (0.2%)		0/462 (0%)
Investigations
Arteriogram Coronary	1/474 (0.2%)		0/462 (0%)
Heart Rate Irregular	0/474 (0%)		1/462 (0.2%)
Hepatic Enzyme Increased	0/474 (0%)		1/462 (0.2%)
Metabolism and nutrition disorders
Diabetes Mellitus	0/474 (0%)		1/462 (0.2%)
Hyperglycemia	0/474 (0%)		1/462 (0.2%)
Hyperkalaemia	1/474 (0.2%)		0/462 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/474 (0.2%)		1/462 (0.2%)
Arthralgia	1/474 (0.2%)		0/462 (0%)
Arthritis	1/474 (0.2%)		0/462 (0%)
Back Pain	0/474 (0%)		1/462 (0.2%)
Intervertebral Disc Protrusion	1/474 (0.2%)		0/462 (0%)
Joint Effusion	0/474 (0%)		1/462 (0.2%)
Muscular Weakness	0/474 (0%)		1/462 (0.2%)
Myositis Ossificans	0/474 (0%)		1/462 (0.2%)
Spinal Osteoarthritis	0/474 (0%)		1/462 (0.2%)
Synovitis	0/474 (0%)		1/462 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer	1/474 (0.2%)		3/462 (0.6%)
Adenolymphoma	1/474 (0.2%)		0/462 (0%)
Benign Lung Cancer	0/474 (0%)		1/462 (0.2%)
Bladder Cancer	1/474 (0.2%)		0/462 (0%)
Brain Neoplasm	1/474 (0.2%)		0/462 (0%)
Breast Cancr Male	1/474 (0.2%)		0/462 (0%)
Colon Cancer	1/474 (0.2%)		0/462 (0%)
Diffuse Large B-Cell Lymphoma	0/474 (0%)		1/462 (0.2%)
Lung Adenocarcinoma	0/474 (0%)		1/462 (0.2%)
Lung Neoplasm Malignant	1/474 (0.2%)		0/462 (0%)
Malignant Melonoma	1/474 (0.2%)		0/462 (0%)
Malignant Neoplasm of Ampulla of Vater	0/474 (0%)		1/462 (0.2%)
Ovarian Cancer Metastatic	1/474 (0.2%)		0/462 (0%)
Renal Cell Carcinoma	0/474 (0%)		1/462 (0.2%)
Small Cell Lung Cancer Metastatic	0/474 (0%)		1/462 (0.2%)
Thyroid Adenoma	0/474 (0%)		1/462 (0.2%)
Transitional Cell Carcinoma	0/474 (0%)		1/462 (0.2%)
Nervous system disorders
Carotid Artery Stenosis	1/474 (0.2%)		0/462 (0%)
Epilepsy	1/474 (0.2%)		0/462 (0%)
Monoplegia	1/474 (0.2%)		0/462 (0%)
Paraesthesia	1/474 (0.2%)		0/462 (0%)
Polyneuropathy	1/474 (0.2%)		0/462 (0%)
Psychiatric disorders
Anxiety	2/474 (0.4%)		0/462 (0%)
Completed Suicide	1/474 (0.2%)		0/462 (0%)
Renal and urinary disorders
Calculus Bladder	0/474 (0%)		1/462 (0.2%)
Calculus Urinary	0/474 (0%)		1/462 (0.2%)
Hematuria	1/474 (0.2%)		0/462 (0%)
Renal Colic	0/474 (0%)		1/462 (0.2%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia	1/474 (0.2%)		0/462 (0%)
Menorrhagia	0/474 (0%)		1/462 (0.2%)
Prostatitis	0/474 (0%)		1/462 (0.2%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Coronary Disorder	1/474 (0.2%)		1/462 (0.2%)
Dyspnea	1/474 (0.2%)		1/462 (0.2%)
Asthma	1/474 (0.2%)		0/462 (0%)
Bronchospasm	1/474 (0.2%)		0/462 (0%)
Epistaxis	1/474 (0.2%)		0/462 (0%)
Hemoptysis	0/474 (0%)		1/462 (0.2%)
Interstitial Lung Disease	0/474 (0%)		1/462 (0.2%)
Pulmonary Embolism	1/474 (0.2%)		0/462 (0%)
Sleep Apnea Syndrome	1/474 (0.2%)		0/462 (0%)
Skin and subcutaneous tissue disorders
Angioedema	1/474 (0.2%)		0/462 (0%)
Drug Eruption	1/474 (0.2%)		0/462 (0%)
Surgical and medical procedures
Cataract Operation	1/474 (0.2%)		0/462 (0%)
Gastrectomy	1/474 (0.2%)		0/462 (0%)
Vascular disorders
Aortic Aneurism	1/474 (0.2%)		1/462 (0.2%)
Hypertension	1/474 (0.2%)		1/462 (0.2%)
Hypertensive Crisis	1/474 (0.2%)		1/462 (0.2%)
Intermittent Claudication	2/474 (0.4%)		0/462 (0%)
Arterial Thrombosis Limb	1/474 (0.2%)		0/462 (0%)
Deep Vein Thrombosis	0/474 (0%)		1/462 (0.2%)
Hematoma	0/474 (0%)		1/462 (0.2%)
Hypotension	1/474 (0.2%)		0/462 (0%)
Other (Not Including Serious) Adverse Events
	Dalcetrapib		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	255/474 (53.8%)		199/462 (43.1%)
Cardiac disorders
Angina Pectoris	30/474 (6.3%)		26/462 (5.6%)
Gastrointestinal disorders
Diarrhea	41/474 (8.6%)		27/462 (5.8%)
General disorders
Chest Pain	48/474 (10.1%)		36/462 (7.8%)
Infections and infestations
Nasopharyngitis	27/474 (5.7%)		22/462 (4.8%)
Musculoskeletal and connective tissue disorders
Back Pain	20/474 (4.2%)		24/462 (5.2%)
Nervous system disorders
Headache	27/474 (5.7%)		23/462 (5%)
Dizziness	24/474 (5.1%)		22/462 (4.8%)
Vascular disorders
Hypertension	38/474 (8%)		19/462 (4.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.