Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
NCT07920133, Not applicable, Not yet recruiting, Sir Run Run Shaw Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD) | ClinicalTrials.gov |
| NCT number | NCT07920133 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 1,768 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sir Run Run Shaw Hospital | ClinicalTrials.gov |
| Conditions | Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD), Residual Inflammatory Risk | ClinicalTrials.gov |
| Interventions | Colchicine (Colcrys®), Colchicine (Colcrys®) | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Major Adverse Cardiovascular Events Through 18 Months | From randomization through 18 months | Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven coronary revascularization. The primary noninferiority comparison is the hazard ratio for the standard hs-CRP target strategy versus the intensive hs-CRP target strategy, with a prespecified margin of 1.30; events are adjudicated by an independent blinded clinical events committee. | ClinicalTrials.gov |
| Secondary | Key Safety Composite Event Through 18 Months | From randomization through 18 months | Time to first occurrence of CTCAE grade ≥3 gastrointestinal adverse reaction, symptomatic creatine kinase elevation or rhabdomyolysis, ≥30% decline in estimated glomerular filtration rate, or drug-related serious adverse event. A superiority comparison of the two randomized strategies is prespecified; the direction and multiplicity sequence must match the final protocol | ClinicalTrials.gov |
| Secondary | Cardiovascular Death Through 18 Months | From randomization through 18 months | Time to cardiovascular death, as adjudicated by the blinded clinical events committee. Time Frame: From randomization through 18 months | ClinicalTrials.gov |
| Secondary | Nonfatal Myocardial Infarction Through 18 Months | From randomization through 18 months | Time to nonfatal myocardial infarction as defined in the protocol and adjudicated by the blinded clinical events committee. | ClinicalTrials.gov |
| Secondary | Nonfatal Ischemic Stroke Through 18 Months | From randomization through 18 months | Time to nonfatal ischemic stroke as defined in the protocol and adjudicated by the blinded clinical events committee. | ClinicalTrials.gov |
| Secondary | Ischemia-Driven Revascularization Through 18 Months | From randomization through 18 months | Time to PCI or coronary bypass surgery performed because of ischemic symptoms or objective evidence of myocardial ischemia | ClinicalTrials.gov |
| Secondary | Change in hs-CRP From Baseline | Baseline and 3, 6, 12, and 18 months | Change in fasting hs-CRP concentration from baseline, expressed in mg/L, at each scheduled follow-up assessment. | ClinicalTrials.gov |
| Secondary | Proportion With hs-CRP <1.0 mg/L | 3, 6, 12, and 18 months | Proportion of evaluated participants with fasting hs-CRP \<1.0 mg/L at each scheduled assessment. | ClinicalTrials.gov |
| Secondary | Proportion With hs-CRP <2.0 mg/L | 3, 6, 12, and 18 months | Proportion of evaluated participants with fasting hs-CRP \<2.0 mg/L at each scheduled assessment. | ClinicalTrials.gov |
| Secondary | Average Daily Colchicine Dose | From randomization through 18 months | Average administered daily colchicine dose in milligrams over the treatment period; exact denominator and handling of interruptions to be specified in the statistical analysis plan. | ClinicalTrials.gov |
| Secondary | Colchicine Dose Reduction | From randomization through 18 months | Proportion of participants with at least one protocol-directed reduction in colchicine dose. | ClinicalTrials.gov |
| Secondary | Colchicine Discontinuation | From randomization through 18 months | Proportion of participants who permanently discontinue protocol-directed colchicine, with reasons recorded | ClinicalTrials.gov |
| Secondary | Cumulative Colchicine Exposure Duration | From randomization through 18 months | Total number of days taking colchicine during study follow-up; interruptions and discontinuations are recorded. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)