Mitral Valve DiseasePhase 4NCT04235569
Warfarin Initiation in Mechanical Mitral Valve Replacement Patients
A Phase 4 study testing Warfarin Sodium 5 MG, Warfarin Sodium 3 MG and Enoxaparin Sodium 100 MG/ML Prefilled Syringe in people with Mitral Valve Disease, run by Sarah Sabry Hashem at 1 site in Egypt.
Trial summary
A prospective, comparative study evaluating warfarin initiation in a dose of 3mg versus 5mg in mechanical mitral valve prostheses patients who received anticoagulation with warfarin with the use of enoxaparen as a bridging agent .Fifty patients were included and compared in terms of the primary outcome time to reach… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Warfarin Sodium 5 MG, Warfarin Sodium 3 MG and Enoxaparin Sodium 100 MG/ML Prefilled Syringe
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- New mechanical mitral valve prostheses patients who will receive anticoagulation with warfarin with the use of enoxaparen as a bridging agent.
Who cannot join
- Pregnant or lactating women
- Renal disorder (GFR = 45< mL/min) or patients on renal dialysis
- Hepatic disorder (Child Pugh class B or C)
- Clinically significant active bleeding.
- Recurrent DVT or PE.
- Baseline INR >1.2
Show all 10Show fewer
- Asian ancestry
- Cancer
- Impaired nutritional status
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Warfarin Initiation at 3mg Versus 5mg for Anticoagulation of Mechanical Mitral Valve Replacement Patients
A prospective, comparative study evaluating warfarin initiation in a dose of 3mg versus 5mg in mechanical mitral valve prostheses patients who received anticoagulation with warfarin with the use of enoxaparen as a bridging agent .Fifty patients were included and compared in terms of the primary outcome time to reach therapeutic INR range.Other outcomes includes proportion of patients who achieved the target INR of 2.0-3.0 between day 3 and day 5, total dose of enoxaparin required for bridging, safety related to both doses of anticoagulants used
Read the detailed description
Inpatients of The Cardiovascular hospital who had undergone mitral heart valve replacement with a mechanical prosthesis and commencing warfarin were eligible for inclusion. Patients were included after they had newly undergone elective surgery for implantation of mechanical mitral heart valves, had commenced on warfarin, received enoxaparin as a bridging agent and had INR monitored for a minimum of 4 consecutive days after warfarin initiation.
A total of 50 consecutive MVR patients were recruited. Each was assigned to either the group I (25 patients) or the group II (25 patients) group. All patients received the conventional postoperative treatment including: Diuretics, beta-blockers, digoxin or heart rate-regulating calcium channel blockers and anticoagulation bridging therapy using LMWH according to the European Society of Cardiology (ESC) Guidelines for the management of MVR and antibiotic for 48hour after surgery according to the investigator's hospital's antibiotic protocol.
Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. were documented for each patient. Medication history in details, as well as the background cardiovascular treatment was considered.
Blood samples were withdrawn from patients for evaluation of INR. Complete blood count, kidney and liver function tests were performed as part of the routine admission care.
All patients were followed up daily post operative till reaching an in range INR value. All patients were observed daily for INR values and dose adjusted accordingly and also estimation of incidence and severity of bleeding complications was done.
- Conditions
- Mitral Valve Disease
- Being tested
- Warfarin Sodium 5 MG, Warfarin Sodium 3 MG, Enoxaparin Sodium 100 MG/ML Prefilled Syringe
- Keywords
- warfarin, anticoagulation, mitral valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin Sodium 5 MGDrug
Also called Marevan 5mg
warfarin sodium 5mg tablets
Warfarin Sodium 3 MGDrug
Also called Marevan 3mg
warfarin sodium 3mg tablets
Enoxaparin Sodium 100 MG/ML Prefilled SyringeDrug
Also called Clexane
Clexane® Syringes 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringes.
Clexane® Syringes 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringes.
Clexane® Syringes 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringes.
Clexane® Syringes 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringes.
Dose was determined individually for each patient as 1mg/kg every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | a group of 25 patients received 5mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range.
Bleeding events due to overanticoagulation were monitored through the follow up period. Receives: Drug: Warfarin Sodium 5 MG; Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe |
| Group II | Experimental | a group of 25 patients received 3mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range.
Bleeding events due to overanticoagulation were monitored through the follow up period. Receives: Drug: Warfarin Sodium 3 MG; Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of warfarin initiating dose and the corresponding dosing schedule: Time to reach therapeutic INR range (TTR)
Time to reach therapeutic INR range (TTR):The time in days required for the patient from the start of warfarin initiation till reaching the therapeutic
Measured: 4-16 days
Secondary outcomes (4)
Evaluation of overanticoagulation
Proportion of patients who achieved the target INR of 2.0-3.0 between day 3 and day 5
Measured: from 3 to 5 days
Anticoagulation Safety evaluation
Incidence of major and minor bleeding events
Measured: from 4 to 16 days
Low Molecular Weight Heparin consumption
The total dose of enoxaparin in mg that the patient received till discontinuation of bridging
Measured: from 4 to 16 days
The Overall cost evaluation
total cost spent in LE during the follow up period calculated by the summation of the cost of treatment , cost of bleeding event management and cost of hospital stay.
Measured: from 4 to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Mar 2018
- Primary completion1 Jan 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Sabry Hashem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Sabry Hashem, Ain Shams University
- Investigators
- Ayman M Saleh, MD, Study director, Ain Shams UniversityLamiaa M ElWakeel, PhD, Study director, Faculty of pharmacy Ain Shams UniversityMarwa A Ahmed, PhD, Study director, Faculty of pharmacy Ain Shams UniversitySarah S Hashem, Msc, Principal investigator, The Cardiovascular Hospital Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235569
- Sponsor's protocol ID
- 11222
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suwanawiboon B, Kongtim P, Chinthammitr Y, Ruchutrakool T, Wanachiwanawin W. The efficacy of 3-mg warfarin initiating dose in adult Thai patients, who required long-term anticoagulant therapy. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S225-31.
PubMed 21721451Roberts G, Razooqi R, Quinn S. Comparing Usual Care With a Warfarin Initiation Protocol After Mechanical Heart Valve Replacement. Ann Pharmacother. 2017 Mar;51(3):219-225. doi: 10.1177/1060028016676830. Epub 2016 Oct 26.
PubMed 27798318Dong L, Shi YK, Xu JP, Zhang EY, Liu JC, Li YX, Ni YM, Yang Q, Han T, Fu B, Chen J, Ren L, Wei SL, Chen H, Liu KX, Yu FX, Liu JS, Xiao MD, Wu SM, Zhang KL, Huang HL, Jiang SL, Qiao CH, Wang CS, Xu ZY, Zhou XM, Wang DJ, Ni LX, Xiao YB, Jiang SL, Zhang GM, Liang GY, Yang SY, Bo P, Zhong QJ, Zhang JB, Zhang X, Zhu YB, Teng X, Zhu P, Huang F, Xiao YM, Cao GQ, Tian H, Xia LM, Lu FL, Liu YQ, Liu DX, Xu H, Yuan Y, Li M, Chang C, Wu XC, Xu Z, Guo P, Bai YJ, Xue WB, Jiang XY, Na ZH, Zeng QY, Cai H, Wang YL, Xiong R, Jin S, Zheng XM, Wu D. [The multicenter study on the registration and follow-up of low anticoagulation therapy for the heart valve operation in China]. Zhonghua Yi Xue Za Zhi. 2016 May 24;96(19):1489-94. doi: 10.3760/cma.j.issn.0376-2491.2016.19.006. Chinese.
PubMed 27266493Bayliss A, Faber P, Dunning J, Ronald A. What is the optimal level of anticoagulation in adult patients receiving warfarin following implantation of a mechanical prosthetic mitral valve? Interact Cardiovasc Thorac Surg. 2007 Jun;6(3):390-6. doi: 10.1510/icvts.2007.152819. Epub 2007 Feb 9.
PubMed 17669876Yoon IK, Lee KE, Lee JK, Chang BC, Gwak HS. Adequate intensity of warfarin therapy for Korean patients with mechanical cardiac valves. J Heart Valve Dis. 2013 Jan;22(1):102-9.
PubMed 23610997Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.
PubMed 28315732Mahtani KR, Heneghan CJ, Nunan D, Bankhead C, Keeling D, Ward AM, Harrison SE, Roberts NW, Hobbs FD, Perera R. Optimal loading dose of warfarin for the initiation of oral anticoagulation. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD008685. doi: 10.1002/14651858.CD008685.pub2.
PubMed 23235665Sabry S, El Wakeel LM, Saleh A, Ahmed MA. Comparison of Warfarin Initiation at 3 mg Versus 5 mg for Anticoagulation of Patients with Mechanical Mitral Valve Replacement Surgery: A Prospective Randomized Trial. Clin Drug Investig. 2022 Apr;42(4):309-318. doi: 10.1007/s40261-022-01137-7. Epub 2022 Mar 10.
PubMed 35274222
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Warfarin Initiation at 3mg Versus 5mg for Anticoagulation of Mechanical Mitral Valve Replacement Patients
- ClinicalTrials.gov ID
- NCT04235569
- Acronym / sponsor ID
- 11222
- Conditions
- Mitral Valve Disease
- Keywords
- warfarin, anticoagulation, mitral valve replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sarah Sabry HashemUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, comparative study evaluating warfarin initiation in a dose of 3mg versus 5mg in mechanical mitral valve prostheses patients who received anticoagulation with warfarin with the use of enoxaparen as a bridging agent .Fifty patients were included and compared in terms of the primary outcome time to reach therapeutic INR range.Other outcomes includes proportion of patients who achieved the target INR of 2.0-3.0 between day 3 and day 5, total dose of enoxaparin required for bridging, safety related to both doses of anticoagulants used
Detailed description
Inpatients of The Cardiovascular hospital who had undergone mitral heart valve replacement with a mechanical prosthesis and commencing warfarin were eligible for inclusion. Patients were included after they had newly undergone elective surgery for implantation of mechanical mitral heart valves, had commenced on warfarin, received enoxaparin as a bridging agent and had INR monitored for a minimum of 4 consecutive days after warfarin initiation.
A total of 50 consecutive MVR patients were recruited. Each was assigned to either the group I (25 patients) or the group II (25 patients) group. All patients received the conventional postoperative treatment including: Diuretics, beta-blockers, digoxin or heart rate-regulating calcium channel blockers and anticoagulation bridging therapy using LMWH according to the European Society of Cardiology (ESC) Guidelines for the management of MVR and antibiotic for 48hour after surgery according to the investigator's hospital's antibiotic protocol.
Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. were documented for each patient. Medication history in details, as well as the background cardiovascular treatment was considered.
Blood samples were withdrawn from patients for evaluation of INR. Complete blood count, kidney and liver function tests were performed as part of the routine admission care.
All patients were followed up daily post operative till reaching an in range INR value. All patients were observed daily for INR values and dose adjusted accordingly and also estimation of incidence and severity of bleeding complications was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Warfarin Sodium 5 MG, Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringea group of 25 patients received 5mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range. Bleeding events due to overanticoagulation were monitored through the follow up period. |
| Group II | Experimental | Drug: Warfarin Sodium 3 MG, Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringea group of 25 patients received 3mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range. Bleeding events due to overanticoagulation were monitored through the follow up period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- New mechanical mitral valve prostheses patients who will receive anticoagulation with warfarin with the use of enoxaparen as a bridging agent.
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Renal disorder (GFR = 45< mL/min) or patients on renal dialysis
- Hepatic disorder (Child Pugh class B or C)
- Clinically significant active bleeding.
- Recurrent DVT or PE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin Sodium 5 MGAlso: Marevan 5mgwarfarin sodium 5mg tablets | Drug | Group I |
| Warfarin Sodium 3 MGAlso: Marevan 3mgwarfarin sodium 3mg tablets | Drug | Group II |
| Enoxaparin Sodium 100 MG/ML Prefilled SyringeAlso: ClexaneClexane® Syringes 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringes. Clexane® Syringes 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringes. Clexane® Syringes 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringes. Clexane® Syringes 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringes. Dose was determined individually for each patient as 1mg/kg every 12 hours. | Drug | Group I, Group II |
Primary outcome
Efficacy of warfarin initiating dose and the corresponding dosing schedule: Time to reach therapeutic INR range (TTR)
Time frame: 4-16 days
Time to reach therapeutic INR range (TTR):The time in days required for the patient from the start of warfarin initiation till reaching the therapeutic
4 secondary outcomes
Evaluation of overanticoagulation
Time frame: from 3 to 5 days
Anticoagulation Safety evaluation
Time frame: from 4 to 16 days
Low Molecular Weight Heparin consumption
Time frame: from 4 to 16 days
The Overall cost evaluation
Time frame: from 4 to 16 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 21721451Suwanawiboon B, Kongtim P, Chinthammitr Y, Ruchutrakool T, Wanachiwanawin W. The efficacy of 3-mg warfarin initiating dose in adult Thai patients, who required long-term anticoagulant therapy. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S225-31.
- Background: PubMed 27798318Roberts G, Razooqi R, Quinn S. Comparing Usual Care With a Warfarin Initiation Protocol After Mechanical Heart Valve Replacement. Ann Pharmacother. 2017 Mar;51(3):219-225. doi: 10.1177/1060028016676830. Epub 2016 Oct 26.
- Background: PubMed 27266493Dong L, Shi YK, Xu JP, Zhang EY, Liu JC, Li YX, Ni YM, Yang Q, Han T, Fu B, Chen J, Ren L, Wei SL, Chen H, Liu KX, Yu FX, Liu JS, Xiao MD, Wu SM, Zhang KL, Huang HL, Jiang SL, Qiao CH, Wang CS, Xu ZY, Zhou XM, Wang DJ, Ni LX, Xiao YB, Jiang SL, Zhang GM, Liang GY, Yang SY, Bo P, Zhong QJ, Zhang JB, Zhang X, Zhu YB, Teng X, Zhu P, Huang F, Xiao YM, Cao GQ, Tian H, Xia LM, Lu FL, Liu YQ, Liu DX, Xu H, Yuan Y, Li M, Chang C, Wu XC, Xu Z, Guo P, Bai YJ, Xue WB, Jiang XY, Na ZH, Zeng QY, Cai H, Wang YL, Xiong R, Jin S, Zheng XM, Wu D. [The multicenter study on the registration and follow-up of low anticoagulation therapy for the heart valve operation in China]. Zhonghua Yi Xue Za Zhi. 2016 May 24;96(19):1489-94. doi: 10.3760/cma.j.issn.0376-2491.2016.19.006. Chinese.
- Background: PubMed 17669876Bayliss A, Faber P, Dunning J, Ronald A. What is the optimal level of anticoagulation in adult patients receiving warfarin following implantation of a mechanical prosthetic mitral valve? Interact Cardiovasc Thorac Surg. 2007 Jun;6(3):390-6. doi: 10.1510/icvts.2007.152819. Epub 2007 Feb 9.
- Background: PubMed 23610997Yoon IK, Lee KE, Lee JK, Chang BC, Gwak HS. Adequate intensity of warfarin therapy for Korean patients with mechanical cardiac valves. J Heart Valve Dis. 2013 Jan;22(1):102-9.
- Background: PubMed 28315732Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.
- Background: PubMed 23235665Mahtani KR, Heneghan CJ, Nunan D, Bankhead C, Keeling D, Ward AM, Harrison SE, Roberts NW, Hobbs FD, Perera R. Optimal loading dose of warfarin for the initiation of oral anticoagulation. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD008685. doi: 10.1002/14651858.CD008685.pub2.
- Derived from this study: PubMed 35274222Sabry S, El Wakeel LM, Saleh A, Ahmed MA. Comparison of Warfarin Initiation at 3 mg Versus 5 mg for Anticoagulation of Patients with Mechanical Mitral Valve Replacement Surgery: A Prospective Randomized Trial. Clin Drug Investig. 2022 Apr;42(4):309-318. doi: 10.1007/s40261-022-01137-7. Epub 2022 Mar 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman M Saleh, MD study director
Ain Shams University
Lamiaa M ElWakeel, PhD study director
Faculty of pharmacy Ain Shams University
Marwa A Ahmed, PhD study director
Faculty of pharmacy Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Warfarin Sodium 5 MG, Warfarin Sodium 3 MG and Enoxaparin Sodium 100 MG/ML Prefilled Syringe in people with Mitral Valve Disease, run by Sarah Sabry Hashem at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of warfarin initiating dose and the corresponding dosing schedule: Time to reach therapeutic INR range (TTR) (time frame: 4-16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235569, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.