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NCT01681095 · ClinicalTrials.gov registry record · Phase 2
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
A Phase 2 study of Coronary Artery Disease and Heart Diseases, sponsored by Marc Sakwa, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT01681095: Completed Phase 2 study of Coronary Artery Disease and Heart Diseases, sponsored by Marc Sakwa, MD.
NCT01681095 is a Phase 2 study of Coronary Artery Disease and Heart Diseases that has completed, run by Marc Sakwa, MD. The registered enrollment target is 110 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681095, a Phase 2 study of Coronary Artery Disease and Heart Diseases, has completed, sponsored by Marc Sakwa, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.
Primary Outcome
Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery
Conditions Studied
Interventions
- DRUG Custodiol HTK
- DRUG Cold Blood Cardioplegia
Study Locations (1)
Michigan
- William Beaumont Hospital - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01681095 record still lists
NCT01681095 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Custodiol HTK is the first listed.
NCT01681095 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01681095 about?
NCT01681095 is a clinical study titled "Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent". The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.
What is the current status of trial NCT01681095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2012-08. Estimated completion is 2016-04.
What conditions does trial NCT01681095 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Heart Diseases, Coronary Disease, Myocardial Ischemia, Valvular Heart Disease.
What interventions are being tested in trial NCT01681095?
The interventions under investigation include: Custodiol HTK (DRUG), Cold Blood Cardioplegia (DRUG).
Who is sponsoring clinical trial NCT01681095?
This trial is sponsored by Marc Sakwa, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01681095 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01681095's enrollment target sits among peer trials
110 141st of 219 higher than 78 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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