ThrombosisNCT02240953
Anticoagulation Regiments in Patients With Prosthetic Heart Valve Thrombosis
A study testing Warfarin, Warfarin + ASA 100 mg + PPI and Warfarin + ASA 300 mg + PPI in people with Thrombosis, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Warfarin, Warfarin + ASA 100 mg + PPI and Warfarin + ASA 300 mg + PPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to Mar 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prosthetic heart valve thrombosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kosuyolu Kartal Heart Training and Research Hospital
Istanbul, 34844
Mehmet Özkan, Prof, 905322551512, memoozkan1@gmail.com
Mehmet Özkan, Professor
About this study
Official title: Comparison of Different Anticoagulation Regiments in Patients With Prosthetic Heart Valve Non-ObstructiveThrombosis
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.
Read the detailed description
Three different anticoagulant treatment regimens for patients with prosthetic heart valve non-obstructive thrombosis have been described. Patients are included in each group randomly. In the first arm only warfarin is given to the patients with a target INR level of 2.5-4. In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin. In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in ombination with warfarin. Also there is an observational follow-up group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4 . All patients are followed by serial transesophageal echocardiography performed every 6 months. Follow-up period is at least 6 months (range 6-60 months). Informed consent is taken from all patients.
- Conditions
- Thrombosis
- Being tested
- Warfarin, Warfarin + ASA 100 mg + PPI, Warfarin + ASA 300 mg + PPI, Observational Warfarin
- Keywords
- Anticoagulation, Prosthetic Heart Valves, Acetylsalicylic acid, Warfarin, Thrombosis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
Warfarin + ASA 100 mg + PPIDrug
100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
Warfarin + ASA 300 mg + PPIDrug
In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
Observational WarfarinDrug
This is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Active comparator | In the first arm only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis Receives: Drug: Warfarin |
| Warfarin + ASA 100 mg + PPI | Active comparator | In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis Receives: Drug: Warfarin + ASA 100 mg + PPI |
| Warfarin + ASA 300 mg + PPI | Active comparator | In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis Receives: Drug: Warfarin + ASA 300 mg + PPI |
| Observational Warfarin | Active comparator | This arm is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4. Receives: Drug: Observational Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased thrombus size
Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
Measured: 6 months
Same thrombus size
Thrombus size remains as similar as the previous transesophageal echocardiographic examination findings in the absence of any fatal and non fatal major complications
Measured: 6 months
Increased thrombus size
Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
Measured: 6 months
Complications
Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion
Nonfatal minor complication: Bleeding without need for transfusion, TIA.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240953
- Sponsor's protocol ID
- KOSUYOLU2
- Status last verified
- Sep 2014
- First submitted
- 12 Sep 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Anticoagulation Regiments in Patients With Prosthetic Heart Valve Non-ObstructiveThrombosis
- ClinicalTrials.gov ID
- NCT02240953
- Acronym / sponsor ID
- KOSUYOLU2
- Conditions
- Thrombosis
- Keywords
- Anticoagulation, Prosthetic Heart Valves, Acetylsalicylic acid, Warfarin, Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kartal Kosuyolu Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- 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.
Prosthetic valve thrombosis is a serious complication with high mortality and morbidity. However, the best anticoagulant treatment strategies for patients with prosthetic heart valve thrombosis have not been fully known. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.
Detailed description
Three different anticoagulant treatment regimens for patients with prosthetic heart valve non-obstructive thrombosis have been described. Patients are included in each group randomly. In the first arm only warfarin is given to the patients with a target INR level of 2.5-4. In the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin. In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in ombination with warfarin. Also there is an observational follow-up group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4 . All patients are followed by serial transesophageal echocardiography performed every 6 months. Follow-up period is at least 6 months (range 6-60 months). Informed consent is taken from all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Warfarin | Active comparator | Drug: WarfarinIn the first arm only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis |
| Warfarin + ASA 100 mg + PPI | Active comparator | Drug: Warfarin + ASA 100 mg + PPIIn the second arm 100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis |
| Warfarin + ASA 300 mg + PPI | Active comparator | Drug: Warfarin + ASA 300 mg + PPIIn the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis |
| Observational Warfarin | Active comparator | Drug: Observational WarfarinThis arm is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with prosthetic heart valve thrombosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| WarfarinOnly warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis | Drug | Warfarin |
| Warfarin + ASA 100 mg + PPI100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis | Drug | Warfarin + ASA 100 mg + PPI |
| Warfarin + ASA 300 mg + PPIIn the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis | Drug | Warfarin + ASA 300 mg + PPI |
| Observational WarfarinThis is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4. | Drug | Observational Warfarin |
Primary outcome
Decreased thrombus size
Time frame: 6 months
Decreased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
Same thrombus size
Time frame: 6 months
Thrombus size remains as similar as the previous transesophageal echocardiographic examination findings in the absence of any fatal and non fatal major complications
Increased thrombus size
Time frame: 6 months
Increased thrombus size on control transesophageal echocardiography in the absence of fatal and non fatal major complications
Complications
Time frame: 6 months
Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion Nonfatal minor complication: Bleeding without need for transfusion, TIA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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.
Kosuyolu Kartal Heart Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin, Warfarin + ASA 100 mg + PPI and Warfarin + ASA 300 mg + PPI in people with Thrombosis, run by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
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 0 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: status not confirmed, as of the sponsor's last update on 16 Sep 2014. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased thrombus size (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2014.