Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users

Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users Undergoing Total Knee Replacement Arthroplasty: RE-STOP-DVT Study- A Prospective Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01063426

Acronym

Re-STOP DVT

Enrollment

180

Registered

2010-02-05

Start date

2009-11-30

Completion date

2012-03-31

Last updated

2010-02-05

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

Conditions

Prevention, Surgery, Thrombosis

Keywords

Statin, Vein

Brief summary

Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in patients on statin undergoing total knee replacement arthroplasty. A body of evidence have been reported that reloading of atorvastatin have efficacy in reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory property. We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.

Interventions

DRUGHigh dose Atorvastatin+enoxaparin

High dose atorvastatin 80mg/day for 7days after index surgery (total knee replacement arthroplasty, TKRA). At the same time Enoxaparin 40mg SQ/day 12hr before TKRA and from 1day to 7day after TKRA should be administered.

DRUGEnoxaparin

Enoxaparin 40mg SQ/day 12hr before TKRA and on day 1 to day7 after TKRA should be administered.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who are going to receive total knee replacement arthroplasty from any cause. * \< 19 years old

Exclusion criteria

* patients with cancer * Patients receiving anticoagulant agents from any cause * current statin users * expecting survival from other co-morbidity \< 1year * Bed ridden patient * AST, ALT \> 3times of upper normal limit * CK\> upper normal limit * pregnancy * patients who receives hormone replacement therapy

Design outcomes

Primary

Measure	Time frame
Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities	7days after index surgery

Secondary

Measure	Time frame
D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP	7days, 1month, 2month after index surgery

Countries

South Korea

Contacts

Primary ContactSang-Ho Jo, MD

sophi5@medimail.co.kr82-31-380-3722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026