Trial Outcomes & Findings for Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS) (NCT NCT00455403)

NCT ID: NCT00455403

Last Updated: 2021-12-15

Results Overview

A noninvasive predictor of cardiovascular events, Carotid artery intima-media thickness (CIMT) was measured from B-mode images by a single sonographer using standard approaches

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 357 participants
• Primary outcome timeframe: Measured at baseline and year 1
• Results posted on: 2021-12-15

Participant Flow

Eligibility included adults with at least 3 criteria of metabolic syndrome but who did not have diabetes. Subjects were studied in the setting of a single academic health center.

241 participants screen failed

Participant milestones

Measure	Chloroquine Subjects Participants will receive 80 mg of chloroquine on a daily basis. Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24	Placebo Subjects Participants will receive a placebo comparator tablet on a daily basis. Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
Overall Study STARTED	59	57
Overall Study COMPLETED	56	51
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Measure	Chloroquine Subjects Participants will receive 80 mg of chloroquine on a daily basis. Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24	Placebo Subjects Participants will receive a placebo comparator tablet on a daily basis. Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	0	2

Baseline Characteristics

Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)

Baseline characteristics by cohort

Measure	Chloroquine Subjects n=59 Participants Participants will receive 80 mg of chloroquine on a daily basis. Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24	Placebo Subjects n=57 Participants Participants will receive a placebo comparator tablet on a daily basis. Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24	Total n=116 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	53 Participants n=7 Participants	104 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 12 • n=5 Participants	55 years STANDARD_DEVIATION 9 • n=7 Participants	55 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	33 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	24 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and year 1

Population: Intent to treat

A noninvasive predictor of cardiovascular events, Carotid artery intima-media thickness (CIMT) was measured from B-mode images by a single sonographer using standard approaches

Outcome measures

Measure	Chloroquine Subjects n=59 Participants Participants will receive 80 mg of chloroquine on a daily basis. Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24	Placebo Subjects n=57 Participants Participants will receive a placebo comparator tablet on a daily basis. Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
Change in Carotid Intima-media Thickness From Baseline to Year 1 Baseline	0.766 millmeter Standard Deviation 0.17	0.765 millmeter Standard Deviation 0.13
Change in Carotid Intima-media Thickness From Baseline to Year 1 Year 1	0.758 millmeter Standard Deviation 0.16	0.768 millmeter Standard Deviation 0.11

Adverse Events

Chloroquine Subjects

Serious events: 5 serious events

Other events: 39 other events

Deaths: 0 deaths

Placebo Subjects

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chloroquine Subjects n=59 participants at risk Participants will receive 80 mg of chloroquine on a daily basis. Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24	Placebo Subjects n=57 participants at risk Participants will receive a placebo comparator tablet on a daily basis. Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
Renal and urinary disorders Prostate Cancer	0.00% 0/59 • 2 years 6 months	1.8% 1/57 • Number of events 1 • 2 years 6 months
Surgical and medical procedures Right Knee Replacement	0.00% 0/59 • 2 years 6 months	1.8% 1/57 • Number of events 1 • 2 years 6 months
Nervous system disorders transverse myelitis	1.7% 1/59 • Number of events 1 • 2 years 6 months	0.00% 0/57 • 2 years 6 months
Surgical and medical procedures carotid endarterectomy	1.7% 1/59 • Number of events 1 • 2 years 6 months	0.00% 0/57 • 2 years 6 months
Infections and infestations cutaneous staphylococcus infection	1.7% 1/59 • Number of events 1 • 2 years 6 months	0.00% 0/57 • 2 years 6 months
Gastrointestinal disorders acute appendicitis	1.7% 1/59 • Number of events 1 • 2 years 6 months	0.00% 0/57 • 2 years 6 months
Infections and infestations positive PPD	1.7% 1/59 • Number of events 1 • 2 years 6 months	0.00% 0/57 • 2 years 6 months

Other adverse events

Measure	Chloroquine Subjects n=59 participants at risk Participants will receive 80 mg of chloroquine on a daily basis. Chloroquine: One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24	Placebo Subjects n=57 participants at risk Participants will receive a placebo comparator tablet on a daily basis. Placebo Comparator: Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
Infections and infestations Infections	66.1% 39/59 • Number of events 51 • 2 years 6 months	64.9% 37/57 • Number of events 42 • 2 years 6 months
Immune system disorders allergy/immunology	8.5% 5/59 • Number of events 51 • 2 years 6 months	17.5% 10/57 • Number of events 42 • 2 years 6 months
Nervous system disorders CNS	8.5% 5/59 • Number of events 51 • 2 years 6 months	5.3% 3/57 • Number of events 57 • 2 years 6 months
Psychiatric disorders Psychiatric	8.5% 5/59 • Number of events 51 • 2 years 6 months	10.5% 6/57 • Number of events 57 • 2 years 6 months
Eye disorders ocular	27.1% 16/59 • Number of events 51 • 2 years 6 months	17.5% 10/57 • Number of events 57 • 2 years 6 months

Additional Information

Janet McGill, MD

Wash. Univ. School of Medicine

Phone: 314-362-8681

Email: jmcgill@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place