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A clinical trial to find out the effect of Atorvastatin on dilatation of forearm blood vessel,in patients with Systemic Sclerosis.

Effect of Atorvastatin on vascular endothelial function in Early Systemic Sclerosis: An open label randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026894
Enrollment
144
Registered
2020-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M349- Systemic sclerosis, unspecified

Interventions

Intervention1: Atorvastatin 40 mg HS for 16 weeks: Patients with Early Systemic Sclerosis who has not received lipid lowering drugs in the last 6 months will be started on Atorvastatin 40 mg HS and co

Sponsors

Intra Mural Research Fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Systemic Sclerosis with a duration of less than 3 years from the first non-Raynauds symptom, classified as per ACR-EULAR 2013 classification criteria 2. Between 18-65 years of age. 3. No use of lipid-lowering medication within last 6 months.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Renal dysfunction 3. Diabetes mellitus 4. Known cardiovascular disease or a prior history of stroke 5. History of liver disease 6. New or changed dose of calcium channel blockers or angiotensin receptor blocker in the last 4 weeks 7. known allergy or adverse reaction to statins. 8. Smoking 9. Overlap syndromes. 10. Patients with digital gangrene despite being on Calcium Channel Blockers and/or Phosphodiesterase inhibitors.

Design outcomes

Primary

MeasureTime frame
1. To assess the effect of Atorvastatin 40 mg per day for 16 weeks on vascular endothelial function of systemic sclerosis patients as measured by Flow mediated dilation of brachial artery. Timepoint: At enrollment and 16 weeks.—

Secondary

MeasureTime frame
1. To look for clinical improvement in Raynauds phenomenon. 2. To look for improvement in measures of macrovascular endothelial dysfunction such as Carotid Intima Medial thickness and Aorto femoral pulse wave velocity. 3. To study the effect of Atorvastatin 40 mg on serological markers of endothelial dysfunction namely hsCRP, von willebrandt factor, oxidized Low Density Lipoprotein and fibrinogen. 4. To look for adverse events related to atorvastatin in the study population. Timepoint: At enrollment and 16 weeks.—

Countries

India

Contacts

Public ContactAnna C Das

JIPMER Puducherry

annakutty1202@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026