Free Rate of Cardiac or Cerebrovascular EventsNCT01704911
Evaluate the Safety And Efficacy of the Transradial Coronary in Comparison With the Transfemoral Coronary Intervention
A study testing Transradial Coronary Intervention, Transfemoral Coronary Intervention and Coronary Stent System in people with Free Rate of Cardiac or Cerebrovascular Events and Transradial-transfemoral Coronary Interventions Comparison, run by CCRF Consulting Co., Ltd. at 1 site in China.
Trial summary
The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the transradial coronary intervention (TRI) in comparison with the transfemoral coronary intervention (TFI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Free Rate of Cardiac or Cerebrovascular Events, Transradial-transfemoral Coronary Interventions Comparison
- What is being tested?
- Transradial Coronary Intervention, Transfemoral Coronary Intervention and Coronary Stent System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be at least 18 years of age.
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides signed informed consent prior to the randomization, as approved by the appropriate IEC.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Allen test is required for suitable candidate.
- Patient must agree to undergo all protocol-required follow-up examinations.
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- Patient must agree not to participate in any other clinical study within the duration of this trial.
- Target lesion must be able to be treated by using six-French guiding catheters.
- Target lesion can be de Novo or restenotic.
- The target lesion can be stable or unstable.
Who cannot join
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
- Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc.).
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Female patients of childbearing potential who have refused a urine or blood pregnancy test (to be done within 7 days prior to index procedure), patients who are nursing at the time of index procedure and those patients who do not agree at the time of consent to use any approved form of birth control up to and including the follow-up at 1 year.
- The target lesion is considered not to be treated by using six-French guiding catheters.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, 100034
Yong Huo, MD, 861084059198 ext. 8528
About this study
Official title: Determination of the Transradial Versus Transfemoral Coronary Angioplasty
The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the transradial coronary intervention (TRI) in comparison with the transfemoral coronary intervention (TFI).
Read the detailed description
Historically, performing PCI requires making an access to the peripheral arteries by an arterial puncture or cutting down. This may lead to the serious bleeding complications especially under the situation of dual antiplatelet therapy and/or potent anti-coagulation therapies. TRI is now widely accepted as the most promising alternative for TFI around the world. It is supposed to reduce the incidence of the serious bleeding complication during and after PCI, as well as the total medical cost. There have been several prospective randomized trials comparing the safety and efficacy between TRI and TFI, but none of them had enough power to show the statistically valid equivalence in the efficacy between TRI and TFI. In this study, investigators randomize approximately 1,700 patients into TRI or TFI. Investigators adopt the rate of major adverse cardiac events (MACCE) at 1 year as the primary efficacy endpoint for the study. Based on these rates at 1 year, the sample size for the non-inferiority analysis for the primary efficacy endpoint is calculated. Through this randomization trial, investigators can achieve the scientific evidence for the improved safety and equal efficacy of TRI compared to TFI. This trial has enough statistical power to draw the final conclusion in the debate between TRI and TFI.
- Conditions
- Free Rate of Cardiac or Cerebrovascular Events, Transradial-transfemoral Coronary Interventions Comparison
- Being tested
- Transradial Coronary Intervention, Transfemoral Coronary Intervention, Coronary Stent System
- Keywords
- Transradial, Transfemoral, Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial Coronary InterventionProcedure or surgery
Transfemoral Coronary InterventionProcedure or surgery
Coronary Stent SystemDevice
Any kind of coronary stent system
| Study group | Role | What they receive |
|---|---|---|
| Transradial Coronary Intervention | Experimental | Transradial Coronary Intervention Receives: Procedure: Transradial Coronary Intervention; Device: Coronary Stent System |
| Transfemoral Coronary Intervention | Experimental | Transfemoral Coronary Intervention Receives: Procedure: Transfemoral Coronary Intervention; Device: Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac or cerebrovascular events free rate
Measured: one year
Secondary outcomes (1)
the major bleeding complication (BARC definition type 3 or 5)-free rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2012
- 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 Free Rate of Cardiac or Cerebrovascular EventsStudies 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
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCRF Consulting Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Terumo Medical (Shanghai) Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Shigeru Saito, MD, Principal investigator, Shonan Kamakura General Hospital, JapanYong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704911
- Sponsor's protocol ID
- DRAGON
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Transradial Versus Transfemoral Coronary Angioplasty
- ClinicalTrials.gov ID
- NCT01704911
- Acronym / sponsor ID
- DRAGON
- Conditions
- Free Rate of Cardiac or Cerebrovascular Events, Transradial-transfemoral Coronary Interventions Comparison
- Keywords
- Transradial, Transfemoral, Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- CCRF Consulting Co., Ltd.University, hospital or other
- Collaborators
- Peking University First Hospital, Terumo Medical (Shanghai) Co.,Ltd.
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 12 Oct 2012 (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.
The purpose of the DRAGON clinical trial is to evaluate the safety and efficacy of the transradial coronary intervention (TRI) in comparison with the transfemoral coronary intervention (TFI).
Detailed description
Historically, performing PCI requires making an access to the peripheral arteries by an arterial puncture or cutting down. This may lead to the serious bleeding complications especially under the situation of dual antiplatelet therapy and/or potent anti-coagulation therapies. TRI is now widely accepted as the most promising alternative for TFI around the world. It is supposed to reduce the incidence of the serious bleeding complication during and after PCI, as well as the total medical cost. There have been several prospective randomized trials comparing the safety and efficacy between TRI and TFI, but none of them had enough power to show the statistically valid equivalence in the efficacy between TRI and TFI. In this study, investigators randomize approximately 1,700 patients into TRI or TFI. Investigators adopt the rate of major adverse cardiac events (MACCE) at 1 year as the primary efficacy endpoint for the study. Based on these rates at 1 year, the sample size for the non-inferiority analysis for the primary efficacy endpoint is calculated. Through this randomization trial, investigators can achieve the scientific evidence for the improved safety and equal efficacy of TRI compared to TFI. This trial has enough statistical power to draw the final conclusion in the debate between TRI and TFI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial Coronary Intervention | Experimental | Procedure: Transradial Coronary Intervention, Device: Coronary Stent SystemTransradial Coronary Intervention |
| Transfemoral Coronary Intervention | Experimental | Procedure: Transfemoral Coronary Intervention, Device: Coronary Stent SystemTransfemoral Coronary Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient must be at least 18 years of age.
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides signed informed consent prior to the randomization, as approved by the appropriate IEC.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Allen test is required for suitable candidate.
Key exclusion criteria (7 listed)
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
- Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. Human Immunodeficiency Virus, Lupus etc.).
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
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 |
|---|---|---|
| Transradial Coronary Intervention | Procedure or surgery | Transradial Coronary Intervention |
| Transfemoral Coronary Intervention | Procedure or surgery | Transfemoral Coronary Intervention |
| Coronary Stent SystemAny kind of coronary stent system | Device | Transfemoral Coronary Intervention, Transradial Coronary Intervention |
Primary outcome
major adverse cardiac or cerebrovascular events free rate
Time frame: one year
1 secondary outcome
the major bleeding complication (BARC definition type 3 or 5)-free rate
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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.
Shigeru Saito, MD principal investigator
Shonan Kamakura General Hospital, Japan
Yong Huo, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transradial Coronary Intervention, Transfemoral Coronary Intervention and Coronary Stent System in people with Free Rate of Cardiac or Cerebrovascular Events and Transradial-transfemoral Coronary Interventions Comparison, run by CCRF Consulting Co., Ltd. at 1 site in China.
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 10 inclusion and 7 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 26 Oct 2012. 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 China. 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?
Contact Yong HUO, MD (861084059198 ext. 8528, ybwang@ccrfmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac or cerebrovascular events free rate (time frame: one year). 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 26 Oct 2012.