Trial design: The effect of high-dose rosuvastatin on echocardiographic parameters in patients with intermediate- and high-risk pulmonary embolism – A randomized placebo-controlled trial
Azin Alizadeh Asl1, Mohamad Mehdi Peighambari2, Jamal Moosavi2, Omid Shafe2, Moona Naghshbandi1, Melody Farrashi1, Nakisa Khansary1, Hamid Reza Pouraliakbar3, Kiara Rezaei Kalantari3, Hooman Bakhshandeh3, Hamed Talakoob3, Maryam Mohseni Salehi3, Sajjad Naderi3, Ehsan Ghourchian3, Farzaneh Mehrvarz2, Nahid Rafiee1, Parham Sadeghipour2
1 Echocardiography Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
2 Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
3 Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Dr. Parham Sadeghipour
Cardiovascular Intervention Research Center, Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Vali-Asr Ave., Hashemi Rafsanjani Exp, Tehran
Source of Support: None, Conflict of Interest: None
Background: It has been shown recently that a considerable burden of pulmonary embolism (PE) roots from an inflammatory response. The activated inflammatory cascade will be responsible for the final fibrotic response of pulmonary vascular bed, creating further mechanical obstruction which results in subsequent right ventricular (RV) dysfunction, influencing functional capacity and future prognosis. Although anticoagulants represent the cornerstone treatment of PE, the drug class has a minimal effect on the mentioned pathology. Study Design: The present study is a single-center randomized, double-blind, parallel group controlled trial with placebo which will evaluate the effect of high-intensity statin – rosuvastatin 20 mg daily on patients with intermediate-to-high-risk PE. Study population will be selected from patients for whom statin is not otherwise indicated. Primary end point of the present trial will be echocardiographic measures of RV function. We believe that the mentioned indexes represent an accurate surrogate for the functional capacity and prognosis. Our secondary end point will be the composites of PE recurrence and exertional capacity measured by 6-minute walk test.
Conclusions: The result of the present trial might influence the complimentary treatment of acute PE.