Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies

Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies Publisher Pubmed

Bikdeli B^{1, 2, 3} ; Talasaz AH⁴ ; Rashidi F⁵ ; Sharifkashani B^{6, 7} ; Farrokhpour M⁸ ; Bakhshandeh H⁹ ; Sezavar H¹⁰ ; Dabbagh A¹¹ ; Beigmohammadi MT¹² ; Payandemehr P¹³ ; Yadollahzadeh M⁸ ; Riahi T¹⁰ ; Khalili H¹⁴ ; Jamalkhani S^{15, 23} Show All Authors

Bikdeli B^{1, 2, 3}
Talasaz AH⁴
Rashidi F⁵
Sharifkashani B^{6, 7}
Farrokhpour M⁸
Bakhshandeh H⁹
Sezavar H¹⁰
Dabbagh A¹¹
Beigmohammadi MT¹²
Payandemehr P¹³
Yadollahzadeh M⁸
Riahi T¹⁰
Khalili H¹⁴
Jamalkhani S^{15, 23}
Rezaeifar P⁵
Abedini A¹⁶
Lookzadeh S¹⁶
Shahmirzaei S¹³
Tahamtan O⁵
Matin S⁵
Amin A⁹
Parhizgar SE⁹
Jimenez D^{17, 18, 19}
Gupta A^{3, 20}
Madhavan MV^{3, 20}
Parikh SA^{3, 20}
Monreal M²¹
Hadavand N⁹
Hajighasemi A⁴
Maleki M⁹
Sadeghian S⁴
Mohebbi B⁹
Piazza G¹
Kirtane AJ^{3, 20}
Lip GYH^{22, 23}
Krumholz HM^{2, 24, 25}
Goldhaber SZ¹
Sadeghipour P^{26, 27}

Source: Thrombosis Research Published:2020

Abstract

Background: Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown. Methods: The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts. Conclusions: INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19. © 2020 Elsevier Ltd

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Azita Hajhossein Talasaz (10)

Hossein Khalili (4)

Style	Citing Format
MLA	Bikdeli B, et al.. "Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies." Thrombosis Research, vol. 196, no. , 2020, pp. 382-394.
APA	Bikdeli B, Talasaz AH, Rashidi F, Sharifkashani B, Farrokhpour M, Bakhshandeh H, Sezavar H, Dabbagh A, Beigmohammadi MT, Payandemehr P, Yadollahzadeh M, Riahi T, Khalili H, Jamalkhani S, Rezaeifar P, Abedini A, Lookzadeh S, Shahmirzaei S, Tahamtan O, ... Sadeghipour P (2020). Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies. Thrombosis Research, 196(), 382-394.
Chicago	Bikdeli B, Talasaz AH, Rashidi F, Sharifkashani B, Farrokhpour M, Bakhshandeh H, Sezavar H, et al.. "Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies." Thrombosis Research 196, no. (2020): 382-394.
Harvard	Bikdeli B et al. (2020) 'Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies', Thrombosis Research, 196(), pp. 382-394.
Vancouver	Bikdeli B, Talasaz AH, Rashidi F, Sharifkashani B, Farrokhpour M, Bakhshandeh H, et al.. Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies. Thrombosis Research. 2020;196():382-394.
BibTex	@article{ author = {Bikdeli B and Talasaz AH and Rashidi F and Sharifkashani B and Farrokhpour M and Bakhshandeh H and Sezavar H and Dabbagh A and Beigmohammadi MT and Payandemehr P and Yadollahzadeh M and Riahi T and Khalili H and Jamalkhani S and Rezaeifar P and Abedini A and Lookzadeh S and Shahmirzaei S and Tahamtan O and Matin S and Amin A and Parhizgar SE and Jimenez D and Gupta A and Madhavan MV and Parikh SA and Monreal M and Hadavand N and Hajighasemi A and Maleki M and Sadeghian S and Mohebbi B and Piazza G and Kirtane AJ and Lip GYH and Krumholz HM and Goldhaber SZ and Sadeghipour P}, title = {Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies}, journal = {Thrombosis Research}, volume = {196}, number = {}, pages = {382-394}, year = {2020} }
RIS	TY - JOUR AU - Bikdeli B AU - Talasaz AH AU - Rashidi F AU - Sharifkashani B AU - Farrokhpour M AU - Bakhshandeh H AU - Sezavar H AU - Dabbagh A AU - Beigmohammadi MT AU - Payandemehr P AU - Yadollahzadeh M AU - Riahi T AU - Khalili H AU - Jamalkhani S AU - Rezaeifar P AU - Abedini A AU - Lookzadeh S AU - Shahmirzaei S AU - Tahamtan O AU - Matin S AU - Amin A AU - Parhizgar SE AU - Jimenez D AU - Gupta A AU - Madhavan MV AU - Parikh SA AU - Monreal M AU - Hadavand N AU - Hajighasemi A AU - Maleki M AU - Sadeghian S AU - Mohebbi B AU - Piazza G AU - Kirtane AJ AU - Lip GYH AU - Krumholz HM AU - Goldhaber SZ AU - Sadeghipour P TI - Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies JO - Thrombosis Research VL - 196 IS - SP - 382 EP - 394 PY - 2020 ER -

Style

Citing Format

MLA

Bikdeli B, et al.. "Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies." Thrombosis Research, vol. 196, no. , 2020, pp. 382-394.

APA

Bikdeli B, Talasaz AH, Rashidi F, Sharifkashani B, Farrokhpour M, Bakhshandeh H, Sezavar H, Dabbagh A, Beigmohammadi MT, Payandemehr P, Yadollahzadeh M, Riahi T, Khalili H, Jamalkhani S, Rezaeifar P, Abedini A, Lookzadeh S, Shahmirzaei S, Tahamtan O, ... Sadeghipour P (2020). Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies. Thrombosis Research, 196(), 382-394.

Chicago

Bikdeli B, Talasaz AH, Rashidi F, Sharifkashani B, Farrokhpour M, Bakhshandeh H, Sezavar H, et al.. "Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies." Thrombosis Research 196, no. (2020): 382-394.

Harvard

Bikdeli B et al. (2020) 'Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies', Thrombosis Research, 196(), pp. 382-394.

Vancouver

Bikdeli B, Talasaz AH, Rashidi F, Sharifkashani B, Farrokhpour M, Bakhshandeh H, et al.. Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies. Thrombosis Research. 2020;196():382-394.

BibTex

@article{ author = {Bikdeli B and Talasaz AH and Rashidi F and Sharifkashani B and Farrokhpour M and Bakhshandeh H and Sezavar H and Dabbagh A and Beigmohammadi MT and Payandemehr P and Yadollahzadeh M and Riahi T and Khalili H and Jamalkhani S and Rezaeifar P and Abedini A and Lookzadeh S and Shahmirzaei S and Tahamtan O and Matin S and Amin A and Parhizgar SE and Jimenez D and Gupta A and Madhavan MV and Parikh SA and Monreal M and Hadavand N and Hajighasemi A and Maleki M and Sadeghian S and Mohebbi B and Piazza G and Kirtane AJ and Lip GYH and Krumholz HM and Goldhaber SZ and Sadeghipour P}, title = {Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies}, journal = {Thrombosis Research}, volume = {196}, number = {}, pages = {382-394}, year = {2020} }

RIS

TY - JOUR
AU - Bikdeli B
AU - Talasaz AH
AU - Rashidi F
AU - Sharifkashani B
AU - Farrokhpour M
AU - Bakhshandeh H
AU - Sezavar H
AU - Dabbagh A
AU - Beigmohammadi MT
AU - Payandemehr P
AU - Yadollahzadeh M
AU - Riahi T
AU - Khalili H
AU - Jamalkhani S
AU - Rezaeifar P
AU - Abedini A
AU - Lookzadeh S
AU - Shahmirzaei S
AU - Tahamtan O
AU - Matin S
AU - Amin A
AU - Parhizgar SE
AU - Jimenez D
AU - Gupta A
AU - Madhavan MV
AU - Parikh SA
AU - Monreal M
AU - Hadavand N
AU - Hajighasemi A
AU - Maleki M
AU - Sadeghian S
AU - Mohebbi B
AU - Piazza G
AU - Kirtane AJ
AU - Lip GYH
AU - Krumholz HM
AU - Goldhaber SZ
AU - Sadeghipour P
TI - Intermediate Versus Standard-Dose Prophylactic Anticoagulation and Statin Therapy Versus Placebo in Critically-Ill Patients With Covid-19: Rationale and Design of the Inspiration/Inspiration-S Studies
JO - Thrombosis Research
VL - 196
IS -
SP - 382
EP - 394
PY - 2020
ER -

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